CDER Therapeutic Biologic Products

This list is intended to include all the Center for Drug Evaluation and Research (CDER) user fee billable therapeutic biological products and potencies approved under Section 351 of the Public Health Service Act The Orange Book includes a section entitled Drug Products with Approval under Section 505 of the Act Administered by CBER Included on that list are several products that have been transferred to CDER which would be considered billable also

Program fees are assessed for each potency in which the approved (non-revoked non-suspended) product is manufactured in final dosage form When evaluating the specific strength or potency of a drug in final dosage form for purposes of assessing program fees for liquid parenteral biological products CDER intends to take into consideration both the total amount of drug substance in mass or units of activity in a product and the concentration of drug substance (mass or units of activity per unit volume of product) Biologic products considered to have a different strength or potency in a final dosage form will be given separate entries in the Biologics List and assessed separate program fees An auto-injector that has the same strength or potency as a prefilled syringe or vial will generally be assessed a separate prescription drug program fee In certain circumstances products which have been discontinued from marketing but are still licensed are not assessed program fees Those products are identified on the CDER Discontinued Biologic Product List section

The potency information contained in this list is based on information in our database Companies are responsible for alerting CDER to any discrepancies regarding potency information For product approvals after October 1 2005 the Biologics License Application Submission Tracking Number (BLA STN) approval date reflects the approval date of the product For product approvals prior to October 1 2005 the BLA STN approval date reflects the approval date of the original BLA Product Number is the FDA assigned number to identify the application products Each strength is a separate product

The list is updated semi-annually ( Latest Update ndash March 2018 )

CDER Billable Biologic Product List

ApplicantLicense No ABBVIE INC 1889

Trade Name HUMIRA

Proper Name ADALIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125057 0 1 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

40 MG08 ML ( 50 MGML )

125057 394 2 11232015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

40 MG04 ML ( 100 MGML )

125057 0 3 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

10 MG02 ML ( 50 MGML )

125057 0 4 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

20 MG04 ML ( 50 MGML )

March 2018 Page 1 of 42

CDER Billable Biologic Product List

ApplicantLicense No

125057 0 5

ABBVIE INC 1889

SOLUTION SUBCUTANEOUS AUTOINJECTOR

40 MG08 ML ( 50 MGML )12312002

125057 0 6 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

10 MG01 ML ( 100 MGML )

125057 0 7 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

20 MG02 ML ( 100 MGML )

125057 0 8 12312002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

40 MG04 ML ( 100 MGML )

125057 0 9 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MG08 ML ( 100 MGML )

125057 0 10 12312002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MG08 ML ( 100 MGML )

ApplicantLicense No AEGERION PHARMACEUTICALS INC 2014

Trade Name MYALEPT

Proper Name METRELEPTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125390 0 1 2242014 113 MG ( 113 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743

Trade Name KANUMA

Proper Name SEBELIPASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125561 0 1 1282015 20 MG10 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name SOLIRIS

March 2018 Page 2 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743

Proper Name ECULIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125166 0 1 3162007 10 MGML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STRENSIQ

Proper Name ASFOTASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125513 0 1 10232015 18 MG045 ML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 2 10232015 80 MG08 ML ( 100 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 3 10232015 28 MG07 ML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 4 10232015 40 MGML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No ALLERGAN INC 1145

Trade Name BOTOX

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 0 1 1291991 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

103000 5101 3 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

103000 5122 5 11102005 200 U ( 200 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

Trade Name BOTOX COSMETIC

March 2018 Page 3 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALLERGAN INC 1145

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 5000 2 4122002 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103000 5101 4 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103951 0 1 9172001 25 MCGML ( 25 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 2 9172001 40 MCGML ( 40 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 3 9172001 60 MCGML ( 60 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 4 9172001 100 MCGML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 6 9172001 200 MCGML ( 200 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 7 9172001 300 MCGML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 15 9172001 500 MCGML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name BLINCYTO

Proper Name BLINATUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125557 0 1 1232014 35 MCG ( 35 MCGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name EPOGEN

Proper Name EPOETIN ALFA

March 2018 Page 5 of 42

CDER Billable Biologic Product List

ApplicantLicense No

125057 0 5

ABBVIE INC 1889

SOLUTION SUBCUTANEOUS AUTOINJECTOR

40 MG08 ML ( 50 MGML )12312002

125057 0 6 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

10 MG01 ML ( 100 MGML )

125057 0 7 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

20 MG02 ML ( 100 MGML )

125057 0 8 12312002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

40 MG04 ML ( 100 MGML )

125057 0 9 12312002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MG08 ML ( 100 MGML )

125057 0 10 12312002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MG08 ML ( 100 MGML )

ApplicantLicense No AEGERION PHARMACEUTICALS INC 2014

Trade Name MYALEPT

Proper Name METRELEPTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125390 0 1 2242014 113 MG ( 113 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743

Trade Name KANUMA

Proper Name SEBELIPASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125561 0 1 1282015 20 MG10 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name SOLIRIS

March 2018 Page 2 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743

Proper Name ECULIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125166 0 1 3162007 10 MGML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STRENSIQ

Proper Name ASFOTASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125513 0 1 10232015 18 MG045 ML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 2 10232015 80 MG08 ML ( 100 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 3 10232015 28 MG07 ML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 4 10232015 40 MGML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No ALLERGAN INC 1145

Trade Name BOTOX

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 0 1 1291991 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

103000 5101 3 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

103000 5122 5 11102005 200 U ( 200 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

Trade Name BOTOX COSMETIC

March 2018 Page 3 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALLERGAN INC 1145

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 5000 2 4122002 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103000 5101 4 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103951 0 1 9172001 25 MCGML ( 25 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 2 9172001 40 MCGML ( 40 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 3 9172001 60 MCGML ( 60 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 4 9172001 100 MCGML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 6 9172001 200 MCGML ( 200 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 7 9172001 300 MCGML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 15 9172001 500 MCGML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name BLINCYTO

Proper Name BLINATUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125557 0 1 1232014 35 MCG ( 35 MCGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name EPOGEN

Proper Name EPOETIN ALFA

March 2018 Page 5 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743

Proper Name ECULIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125166 0 1 3162007 10 MGML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STRENSIQ

Proper Name ASFOTASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125513 0 1 10232015 18 MG045 ML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 2 10232015 80 MG08 ML ( 100 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 3 10232015 28 MG07 ML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

125513 0 4 10232015 40 MGML ( 40 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No ALLERGAN INC 1145

Trade Name BOTOX

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 0 1 1291991 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

103000 5101 3 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

103000 5122 5 11102005 200 U ( 200 UVIAL )

POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL

Trade Name BOTOX COSMETIC

March 2018 Page 3 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALLERGAN INC 1145

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 5000 2 4122002 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103000 5101 4 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103951 0 1 9172001 25 MCGML ( 25 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 2 9172001 40 MCGML ( 40 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 3 9172001 60 MCGML ( 60 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 4 9172001 100 MCGML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 6 9172001 200 MCGML ( 200 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 7 9172001 300 MCGML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 15 9172001 500 MCGML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name BLINCYTO

Proper Name BLINATUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125557 0 1 1232014 35 MCG ( 35 MCGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name EPOGEN

Proper Name EPOETIN ALFA

March 2018 Page 5 of 42

CDER Billable Biologic Product List

ApplicantLicense No ALLERGAN INC 1145

Proper Name BOTULINUM TOXIN TYPE A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103000 5000 2 4122002 100 U ( 100 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103000 5101 4 4142005 50 U ( 50 UVIAL )

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103951 0 1 9172001 25 MCGML ( 25 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 2 9172001 40 MCGML ( 40 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 3 9172001 60 MCGML ( 60 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 4 9172001 100 MCGML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 6 9172001 200 MCGML ( 200 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 7 9172001 300 MCGML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 15 9172001 500 MCGML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name BLINCYTO

Proper Name BLINATUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125557 0 1 1232014 35 MCG ( 35 MCGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name EPOGEN

Proper Name EPOETIN ALFA

March 2018 Page 5 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 15 9172001 500 MCGML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name BLINCYTO

Proper Name BLINATUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125557 0 1 1232014 35 MCG ( 35 MCGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name EPOGEN

Proper Name EPOETIN ALFA

March 2018 Page 5 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103234 0 6 611989 10000 UML ( 10000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

103234 0 7 611989 20000 UML ( 10000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

Proper Name EPOETIN ALFA - PRESERVATIVE FREE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103234 0 1 611989 2000 UML ( 2000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103234 0 2 611989 3000 UML ( 3000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103234 0 3 611989 4000 UML ( 4000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103234 0 4 611989 10000 UML ( 10000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name NEULASTA

Proper Name PEGFILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125031 0 1 1312002 6 MG06 ML ( 10 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name NEULASTA ONPRO

Proper Name PEGFILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125031 181 2 9232015 6 MG06 ML ( 10 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name NEUPOGEN

March 2018 Page 6 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

Proper Name FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103353 0 1 2201991 300 MCGML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name NPLATE

Proper Name ROMIPLOSTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125268 0 1 8222008 250 MCG ( 250 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125268 0 2 8222008 500 MCG ( 500 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name PROCRIT

Proper Name EPOETIN ALFA - PRESERVATIVE FREE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103234 0 5 611989 40000 UML ( 40000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name PROLIA

Proper Name DENOSUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 7 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

125320 0 1 612010 60 MGML ( 60 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name REPATHA

Proper Name EVOLOCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125522 0 1 8272015 140 MGML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125522 1 2 7112016 420 MG35 ML ( 120 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125522 0 3 8272015 140 MGML ( 140 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name VECTIBIX

Proper Name PANITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125147 0 1 9272006 100 MG5 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125147 0 2 9272006 200 MG10 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125147 0 3 9272006 400 MG20 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XGEVA

Proper Name DENOSUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125320 7 2 11182010 120 MG17 ML ( 70 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 42

CDER Billable Biologic Product List

ApplicantLicense No ASTRAZENECA UK LTD 2043

Trade Name FASENRA

Proper Name BENRALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761070 0 1 11142017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

30 MGML ( 30 MGML )

Trade Name

Proper Name

IMFINZI

DURVALUMAB

BLASTN

761069 0

Product

1

Approval Date

512017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

120 MG24 ML ( 50 MGML )

761069 0 2 512017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG10 ML ( 50 MGML )

ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816

Trade Name XIAFLEX

Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125338 0 1 222010 09 MG ( 09 MGVIAL )

POWDER INTRALESIONAL SINGLE-DOSE VIAL

ApplicantLicense No AYTU BIOSCIENCES INC 2035

Trade Name PROSTASCINT

Proper Name CAPROMAB PENDETIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103608 0 1 10281996 05 MGML ( 05 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 42

CDER Billable Biologic Product List

ApplicantLicense No BAXALTA US INC 2020

Trade Name ONCASPAR

Proper Name PEGASPARGASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103411 0 1 211994 3750 IU5 ML ( 750 IUML )

SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778

Trade Name BETASERON

Proper Name INTERFERON BETA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103471 0 1 7231993 03 MG ( 03 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No BIOGEN INC 1697

Trade Name AVONEX

Proper Name INTERFERON BETA 1A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103628 0 1 5171996

POWDER INTRAMUSCULAR

30 MCG ( 30 MCGVIAL )

SINGLE-DOSE VIAL

103628 0 2 5171996

SOLUTION INTRAMUSCULAR PREFILLED SYRINGE

30 MCG05 ML ( 30 MCG05 ML )

103628 0 3 5171996

SOLUTION INTRAMUSCULAR AUTOINJECTOR

30 MCG05 ML ( 30 MCG05 ML )

Trade Name

Proper Name

BLASTN

125499 0

PLEGRIDY

PEGINTERFERON BETA-1A

Approval Date PotencyDosage FormRoutePresentation Product

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

63 MCG05 ML ( 126 MCGML ) 8152014 1

March 2018 Page 10 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOGEN INC 1697

125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name TYSABRI

Proper Name NATALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125104 0 1 11232004 300 MG15 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name ZINBRYTA

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761029 0 1 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

761029 0 2 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 11 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

Proper Name FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103353 0 1 2201991 300 MCGML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

Trade Name NPLATE

Proper Name ROMIPLOSTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125268 0 1 8222008 250 MCG ( 250 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125268 0 2 8222008 500 MCG ( 500 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name PROCRIT

Proper Name EPOETIN ALFA - PRESERVATIVE FREE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103234 0 5 611989 40000 UML ( 40000 UML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name PROLIA

Proper Name DENOSUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 7 of 42

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

125320 0 1 612010 60 MGML ( 60 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name REPATHA

Proper Name EVOLOCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125522 0 1 8272015 140 MGML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125522 1 2 7112016 420 MG35 ML ( 120 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125522 0 3 8272015 140 MGML ( 140 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name VECTIBIX

Proper Name PANITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125147 0 1 9272006 100 MG5 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125147 0 2 9272006 200 MG10 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125147 0 3 9272006 400 MG20 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XGEVA

Proper Name DENOSUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125320 7 2 11182010 120 MG17 ML ( 70 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 42

CDER Billable Biologic Product List

ApplicantLicense No ASTRAZENECA UK LTD 2043

Trade Name FASENRA

Proper Name BENRALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761070 0 1 11142017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

30 MGML ( 30 MGML )

Trade Name

Proper Name

IMFINZI

DURVALUMAB

BLASTN

761069 0

Product

1

Approval Date

512017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

120 MG24 ML ( 50 MGML )

761069 0 2 512017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG10 ML ( 50 MGML )

ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816

Trade Name XIAFLEX

Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125338 0 1 222010 09 MG ( 09 MGVIAL )

POWDER INTRALESIONAL SINGLE-DOSE VIAL

ApplicantLicense No AYTU BIOSCIENCES INC 2035

Trade Name PROSTASCINT

Proper Name CAPROMAB PENDETIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103608 0 1 10281996 05 MGML ( 05 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 42

CDER Billable Biologic Product List

ApplicantLicense No BAXALTA US INC 2020

Trade Name ONCASPAR

Proper Name PEGASPARGASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103411 0 1 211994 3750 IU5 ML ( 750 IUML )

SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778

Trade Name BETASERON

Proper Name INTERFERON BETA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103471 0 1 7231993 03 MG ( 03 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No BIOGEN INC 1697

Trade Name AVONEX

Proper Name INTERFERON BETA 1A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103628 0 1 5171996

POWDER INTRAMUSCULAR

30 MCG ( 30 MCGVIAL )

SINGLE-DOSE VIAL

103628 0 2 5171996

SOLUTION INTRAMUSCULAR PREFILLED SYRINGE

30 MCG05 ML ( 30 MCG05 ML )

103628 0 3 5171996

SOLUTION INTRAMUSCULAR AUTOINJECTOR

30 MCG05 ML ( 30 MCG05 ML )

Trade Name

Proper Name

BLASTN

125499 0

PLEGRIDY

PEGINTERFERON BETA-1A

Approval Date PotencyDosage FormRoutePresentation Product

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

63 MCG05 ML ( 126 MCGML ) 8152014 1

March 2018 Page 10 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOGEN INC 1697

125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name TYSABRI

Proper Name NATALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125104 0 1 11232004 300 MG15 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name ZINBRYTA

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761029 0 1 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

761029 0 2 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 11 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No AMGEN INC 1080

125320 0 1 612010 60 MGML ( 60 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name REPATHA

Proper Name EVOLOCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125522 0 1 8272015 140 MGML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125522 1 2 7112016 420 MG35 ML ( 120 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125522 0 3 8272015 140 MGML ( 140 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name VECTIBIX

Proper Name PANITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125147 0 1 9272006 100 MG5 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125147 0 2 9272006 200 MG10 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125147 0 3 9272006 400 MG20 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XGEVA

Proper Name DENOSUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125320 7 2 11182010 120 MG17 ML ( 70 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 42

CDER Billable Biologic Product List

ApplicantLicense No ASTRAZENECA UK LTD 2043

Trade Name FASENRA

Proper Name BENRALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761070 0 1 11142017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

30 MGML ( 30 MGML )

Trade Name

Proper Name

IMFINZI

DURVALUMAB

BLASTN

761069 0

Product

1

Approval Date

512017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

120 MG24 ML ( 50 MGML )

761069 0 2 512017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG10 ML ( 50 MGML )

ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816

Trade Name XIAFLEX

Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125338 0 1 222010 09 MG ( 09 MGVIAL )

POWDER INTRALESIONAL SINGLE-DOSE VIAL

ApplicantLicense No AYTU BIOSCIENCES INC 2035

Trade Name PROSTASCINT

Proper Name CAPROMAB PENDETIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103608 0 1 10281996 05 MGML ( 05 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 42

CDER Billable Biologic Product List

ApplicantLicense No BAXALTA US INC 2020

Trade Name ONCASPAR

Proper Name PEGASPARGASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103411 0 1 211994 3750 IU5 ML ( 750 IUML )

SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778

Trade Name BETASERON

Proper Name INTERFERON BETA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103471 0 1 7231993 03 MG ( 03 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No BIOGEN INC 1697

Trade Name AVONEX

Proper Name INTERFERON BETA 1A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103628 0 1 5171996

POWDER INTRAMUSCULAR

30 MCG ( 30 MCGVIAL )

SINGLE-DOSE VIAL

103628 0 2 5171996

SOLUTION INTRAMUSCULAR PREFILLED SYRINGE

30 MCG05 ML ( 30 MCG05 ML )

103628 0 3 5171996

SOLUTION INTRAMUSCULAR AUTOINJECTOR

30 MCG05 ML ( 30 MCG05 ML )

Trade Name

Proper Name

BLASTN

125499 0

PLEGRIDY

PEGINTERFERON BETA-1A

Approval Date PotencyDosage FormRoutePresentation Product

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

63 MCG05 ML ( 126 MCGML ) 8152014 1

March 2018 Page 10 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOGEN INC 1697

125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name TYSABRI

Proper Name NATALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125104 0 1 11232004 300 MG15 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name ZINBRYTA

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761029 0 1 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

761029 0 2 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 11 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No ASTRAZENECA UK LTD 2043

Trade Name FASENRA

Proper Name BENRALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761070 0 1 11142017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

30 MGML ( 30 MGML )

Trade Name

Proper Name

IMFINZI

DURVALUMAB

BLASTN

761069 0

Product

1

Approval Date

512017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

120 MG24 ML ( 50 MGML )

761069 0 2 512017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG10 ML ( 50 MGML )

ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816

Trade Name XIAFLEX

Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125338 0 1 222010 09 MG ( 09 MGVIAL )

POWDER INTRALESIONAL SINGLE-DOSE VIAL

ApplicantLicense No AYTU BIOSCIENCES INC 2035

Trade Name PROSTASCINT

Proper Name CAPROMAB PENDETIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103608 0 1 10281996 05 MGML ( 05 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 42

CDER Billable Biologic Product List

ApplicantLicense No BAXALTA US INC 2020

Trade Name ONCASPAR

Proper Name PEGASPARGASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103411 0 1 211994 3750 IU5 ML ( 750 IUML )

SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778

Trade Name BETASERON

Proper Name INTERFERON BETA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103471 0 1 7231993 03 MG ( 03 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No BIOGEN INC 1697

Trade Name AVONEX

Proper Name INTERFERON BETA 1A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103628 0 1 5171996

POWDER INTRAMUSCULAR

30 MCG ( 30 MCGVIAL )

SINGLE-DOSE VIAL

103628 0 2 5171996

SOLUTION INTRAMUSCULAR PREFILLED SYRINGE

30 MCG05 ML ( 30 MCG05 ML )

103628 0 3 5171996

SOLUTION INTRAMUSCULAR AUTOINJECTOR

30 MCG05 ML ( 30 MCG05 ML )

Trade Name

Proper Name

BLASTN

125499 0

PLEGRIDY

PEGINTERFERON BETA-1A

Approval Date PotencyDosage FormRoutePresentation Product

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

63 MCG05 ML ( 126 MCGML ) 8152014 1

March 2018 Page 10 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOGEN INC 1697

125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name TYSABRI

Proper Name NATALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125104 0 1 11232004 300 MG15 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name ZINBRYTA

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761029 0 1 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

761029 0 2 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 11 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No BAXALTA US INC 2020

Trade Name ONCASPAR

Proper Name PEGASPARGASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103411 0 1 211994 3750 IU5 ML ( 750 IUML )

SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778

Trade Name BETASERON

Proper Name INTERFERON BETA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103471 0 1 7231993 03 MG ( 03 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No BIOGEN INC 1697

Trade Name AVONEX

Proper Name INTERFERON BETA 1A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103628 0 1 5171996

POWDER INTRAMUSCULAR

30 MCG ( 30 MCGVIAL )

SINGLE-DOSE VIAL

103628 0 2 5171996

SOLUTION INTRAMUSCULAR PREFILLED SYRINGE

30 MCG05 ML ( 30 MCG05 ML )

103628 0 3 5171996

SOLUTION INTRAMUSCULAR AUTOINJECTOR

30 MCG05 ML ( 30 MCG05 ML )

Trade Name

Proper Name

BLASTN

125499 0

PLEGRIDY

PEGINTERFERON BETA-1A

Approval Date PotencyDosage FormRoutePresentation Product

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

63 MCG05 ML ( 126 MCGML ) 8152014 1

March 2018 Page 10 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOGEN INC 1697

125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name TYSABRI

Proper Name NATALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125104 0 1 11232004 300 MG15 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name ZINBRYTA

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761029 0 1 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

761029 0 2 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 11 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No BIOGEN INC 1697

125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name TYSABRI

Proper Name NATALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125104 0 1 11232004 300 MG15 ML ( 20 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name ZINBRYTA

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761029 0 1 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

761029 0 2 5272016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 11 of 42

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649

Trade Name ALDURAZYME

Proper Name LARONIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125058 0 1 4302003

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

29 MG5 ML ( 058 MGML )

Trade Name

Proper Name

BRINEURA

CERLIPONASE ALFA

BLASTN

761052 0

Product

1

Approval Date

4272017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL

150 MG5 ML ( 30 MGML )

Trade Name

Proper Name

NAGLAZYME

GALSULFASE

BLASTN

125117 0

Product

1

Approval Date

5312005

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG 5ML ( 1 MGML )

Trade Name

Proper Name

VIMIZIM

ELOSULFASE ALFA

BLASTN

125460 0

Product

1

Approval Date

2142014

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

5 MG5 ML ( 1 MGML )

ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006

Trade Name PRAXBIND

Proper Name IDARUCIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761025 0 1 10162015 2500 MG50 ML ( 50 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 12 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

Trade Name EMPLICITI

Proper Name ELOTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761035 0 1 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

300 MG ( 300 MGVIAL )

761035 0 2 11302015

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

Trade Name

Proper Name

BLASTN

125288 0

NULOJIX

BELATACEPT

Approval Date Product

6152011 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

Trade Name

Proper Name

BLASTN

125554 0

OPDIVO

NIVOLUMAB

Approval Date Product

12222014 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

40 MG4 ML ( 10 MGML )

125554 0 2 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125554 0 3 12222014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

240 MG24 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

125118 0

ORENCIA

ABATACEPT

Approval Date Product

12232005 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

250 MG ( 250 MGVIAL )

March 2018 Page 13 of 42

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713

125118 122 2 7292011 50 MG04 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 3 7292011 875 MG07 ML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 4 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125118 122 5 7292011 125 MGML ( 125 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name YERVOY

Proper Name IPILIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125377 0 1 3252011 50 MG10 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125377 0 2 3252011 200 MG40 ML ( 5 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No BTG INTERNATIONAL INC 1861

Trade Name VORAXAZE

Proper Name GLUCARPIDASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125327 0 1 1172012 1000 U ( 1000 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 14 of 42

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No DYAX CORPORATION 1789

Trade Name KALBITOR

Proper Name ECALLANTIDE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125277 0 1 1212009 10 MGML ( 10 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No EKR THERAPEUTICS INC 1814

Trade Name RETAVASE

Proper Name RETEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103786 0 1 561998 10 U ( 10 UVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name CYRAMZA

Proper Name RAMUCIRUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125477 0 1 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG10 ML ( 10 MGML )

125477 0 2 4212014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

Trade Name

Proper Name

BLASTN

761038 0

LARTRUVO

OLARATUMAB

Approval Date Product

10192016 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

500 MG50 ML ( 10 MGML )

761038 0 2 10192016

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

190 MG19 ML ( 10 MGML )

March 2018 Page 15 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No ELI LILLY AND CO 1891

Trade Name PORTRAZZA

Proper Name NECITUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125547 0 1 11242015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

800 MG50 ML ( 16 MGML )

Trade Name

Proper Name

TALTZ

IXEKIZUMAB

BLASTN

125521 0

Product

1

Approval Date

3222016

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

80 MGML ( 80 MGML )

125521 0 2 3222016

SOLUTION SUBCUTANEOUS AUTOINJECTOR

80 MGML ( 80 MGML )

Trade Name

Proper Name

TRULICITY

DULAGLUTIDE

BLASTN

125469 0

Product

1

Approval Date

9182014

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

075 MG05 ML ( 075 MG05 ML )

125469 0 2 9182014

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

15 MG05 ML ( 15 MG05 ML )

125469 0 3 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

075 MG05 ML ( 075 MG05 ML )

125469 0 4 9182014

SOLUTION SUBCUTANEOUS AUTOINJECTOR

15 MG05 ML ( 15 MG05 ML )

March 2018 Page 16 of 42

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No ELUSYS THERAPEUTICS INC 1907

Trade Name ANTHIM

Proper Name OBILTOXAXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125509 1 1 3182016 600 MG6 ML ( 100 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No EMD SERONO INC 1773

Trade Name BAVENCIO

Proper Name AVELUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761049 0 1 3232017

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103780 0

REBIF

INTERFERON BETA 1A

Approval Date Product

372002 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

88 MCG02 ML ( 44 MCGML )

103780 0 2 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

88 MCG02 ML ( 44 MCGML )

103780 0 3 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

22 MCG05 ML ( 44 MCGML )

103780 0 4 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

22 MCG05 ML ( 44 MCGML )

103780 0 5 372002

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

44 MCG05 ML ( 88 MCGML )

103780 0 6 372002

SOLUTION SUBCUTANEOUS AUTOINJECTOR

44 MCG05 ML ( 88 MCGML )

March 2018 Page 17 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name ACTEMRA

Proper Name TOCILIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125276 0 1 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

80 MG4 ML ( 20 MGML )

125276 0 2 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

200 MG10 ML ( 20 MGML )

125276 0 3 182010

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

BLASTN

125472 1

Product

1

Approval Date

10212013

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

162 MG09 ML ( 179 MGML )

Trade Name

Proper Name

BLASTN

103172 0

ACTIVASE

ALTEPLASE

Approval Date Product

11131987 2

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

50 MG ( 50 MGVIAL )

103172 0 3 11131987

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

125085 0

AVASTIN

BEVACIZUMAB

Approval Date Product

2262004 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG4 ML ( 25 MGML )

125085 0 2 2262004

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

400 MG16 ML ( 25 MGML )

March 2018 Page 18 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name CATHFLO ACTIVASE

Proper Name ALTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103172 0 1 11131987

POWDER INTRACATHETER SINGLE-DOSE VIAL

2 MG ( 2 MGVIAL )

Trade Name

Proper Name

BLASTN

125486 0

GAZYVA

OBINUYUZUMAB

Approval Date Product

1112013 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG40 ML ( 25 MGML )

Trade Name

Proper Name

BLASTN

761083 0

HEMLIBRA

EMICIZUMAB-KXWH

Approval Date Product

11162017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

761083 0 2 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

60 MG04 ML ( 150 MGML )

761083 0 3 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

105 MG07 ML ( 150 MGML )

761083 0 4 11162017

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

103792 0

HERCEPTIN

TRASTUZUMAB

Approval Date Product

9251998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS MULTI-DOSE VIAL

420 MG ( 420 MGVIAL )

March 2018 Page 19 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

103792 5336 2 2102017 150 MG ( 150 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KADCYLA

Proper Name ADO-TRASIUZUMAB EMTANSINE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125427 0 1 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

125427 0 2 2222013

POWDER INTRAVENOUS SINGLE-DOSE VIAL

160 MG ( 160 MGVIAL )

Trade Name

Proper Name

LUCENTIS

RANIBIZUMAB

BLASTN

125156 0

Product

1

Approval Date

6302006

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

05 MG005 ML ( 10 MGML )

Proper Name RANIDIZUMAB

BLASTN

125156 076

Product

2

Approval Date

8102012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE

03 MG005 ML ( 6 MGML )

Trade Name

Proper Name

OCREVUS

OCRELIZUMAB

BLASTN

761053 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MG10 ML ( 30 MGML )

Trade Name

Proper Name

PERJETA

PERTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 20 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

125409 0 1 682012 420 MG14 ML ( 30 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PULMOZYME

Proper Name DORNASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103532 0 1 12301993 25 MG25 ML ( 1 MGML )

SOLUTION INHALATION AMPULE

Trade Name RITUXAN

Proper Name RITUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103705 0 1 11261997 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

103705 0 2 11261997 500 MG50 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name RITUXAN HYCELA

Proper Name RITUXIMAB AND HYALURONIDASE HUMAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name TECENTRIQ

Proper Name ATEZOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761034 0 1 582016 1200 MG20 ML ( 60 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name TNKASE

March 2018 Page 21 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Proper Name TENECTEPLASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103909 0 1 622000 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103976 0 1 6202003 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103948 0 1 572001

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML )

Trade Name

Proper Name

FABRAZYME

AGALSIDASE BETA

BLASTN

103979 0

Product

1

Approval Date

4242003

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

5 MG ( 5 MGVIAL )

103979 0 2 4242003

POWDER INTRAVENOUS SINGLE-DOSE VIAL

35 MG ( 35 MGVIAL )

Trade Name

Proper Name

LEMTRADA

ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 22 of 42

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No GENZYME CORP 1596

103948 5139 2 11142014 12 MG12 ML ( 10MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name LUMIZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125291 0 1 5242010 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name NUCALA

Proper Name MEPOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125526 0 1 11142015

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

TANZEUM

ALBIGLUTIDE

BLASTN

125431 0

Product

1

Approval Date

4152014

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS AUTOINJECTOR

30 MG ( 30 MGAUTOINJECTOR )

125431 0 2 4152014

POWDER SUBCUTANEOUS AUTOINJECTOR

50 MG ( 50 MGAUTOINJECTOR )

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name PEGASYS

Proper Name PEGINTERFERON ALFA 2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 23 of 42

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Proper Name PEG-INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103964 0 1 10162002 180 MCGML ( 180 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022

Trade Name ACTIMMUNE

Proper Name INTERFERON GAMMA-1B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998

Trade Name KRYSTEXXA

Proper Name PEGLOTICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125293 0 1 9142010 8MGML ( 8MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 24 of 42

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No HUMAN GENOME SCIENCES INC 1820

Trade Name BENLYSTA

Proper Name BELIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125370 0 1 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

120 MG ( 120 MGVIAL )

125370 0 2 392011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

400 MG ( 400 MGVIAL )

125370 0 3 392011

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

125370 0 4 392011

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MGML ( 200 MGML )

BLASTN

761043 0

Product

1

Approval Date

7202017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )

Trade Name

Proper Name

RAXIBACUMAB

RAXIBACUMAB

BLASTN

125349 0

Product

1

Approval Date

12142012

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1700 MG34 ML ( 50 MGML )

ApplicantLicense No IMCLONE LLC 1695

Trade Name ERBITUX

Proper Name CETUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125084 0 1 2122004 100 MG50 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 25 of 42

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No IMCLONE LLC 1695

125084 0 2 2122004 200 MG100 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No IMMUNEX CORP 1132

Trade Name ENBREL

Proper Name ETANERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103795 0 1 1121998

POWDER SUBCUTANEOUS MULTI-DOSE VIAL

25 MG ( 25 MGVIAL )

103795 5184 2 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MGML ( 50 MGML )

103795 0 3 9272004

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

103795 5184 4 9272004

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

25 MG05 ML ( 50 MGML )

103795 5556 5 9142017

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MGML ( 50 MGML )

ApplicantLicense No IPSEN BIOPHARM LIMITED 1787

Trade Name DYSPORT

Proper Name ABOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125274 0 1 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

300 UNITS ( 300 UNITSVIAL )

125274 0 2 4292009

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

500 UNITS ( 500 UNITSVIAL )

March 2018 Page 26 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name DARZALEX

Proper Name DARATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761036 0 1 11162015

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

761036 0 2 11162015

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

400 MG20 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

103772 0

REMICADE

INFLIXIMAB

Approval Date Product

8241998 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUS SINGLE-DOSE VIAL

100 MG ( 100 MGVIAL )

Trade Name

Proper Name

BLASTN

103575 0

REOPRO

ABCIXIMAB

Approval Date Product

12221994 1

PotencyDosage FormRoutePresentation

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

10 MG5 ML ( 2 MGML )

Trade Name

Proper Name

BLASTN

125289 0

SIMPONI

GOLIMUMAB

Approval Date Product

4242009 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

50 MG05 ML ( 100 MGML )

125289 0 2 4242009

SOLUTION SUBCUTANEOUS AUTOINJECTOR

50 MG05 ML ( 100 MGML )

125289 0 3 4242009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

100 MGML ( 100 MGML )

March 2018 Page 27 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

125289 0 4 4242009 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name SIMPONI ARIA

Proper Name GOLIMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125433 0 1 7182013 50 MG4 ML ( 125 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name STELARA

Proper Name USTEKINUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125261 0 1 9252009 90 MGML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125261 0 2 9252009 45 MG05 ML ( 90 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE

125261 0 3 9252009 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761044 0 1 9232016 130 MG26 ML ( 5 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLVANT

Proper Name SILTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125496 0 1 4232014 100 MG ( 100 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125496 0 2 4232014 400 MG ( 400 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 28 of 42

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No JANSSEN BIOTECH INC 1864

Trade Name TREMFYA

Proper Name GUSELKUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761061 0 1 7132017 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901

Trade Name ERWINAZE

Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

105359 0 1 11182011 10000 IU ( 10000 IUVIAL )

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103770 0 1 6191998

SOLUTION INTRAMUSCULAR

50 MG05 ML ( 100 MGML )

SINGLE-DOSE VIAL

103770 0 2 6191998

SOLUTION INTRAMUSCULAR

100 MGML ( 100 MGML )

SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name ILUMYA

Proper Name TILDRAKIZUMAB-ASMN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761067 0 1 3202018 100 MGML ( 100 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name INTRON A

March 2018 Page 29 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103132 0 1 641986 10 MIU ( 10 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL

103132 0 2 641986 18 MIU ( 18 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 3 641986 50 MIU ( 50 MIUVIAL )

POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL

103132 0 4 641986 228 MIU38 ML ( 6 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL

103132 0 5 641986 32 MIU32 ML ( 10 MIUML )

SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL

Trade Name KEYTRUDA

Proper Name PEMBROLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125514 0 1 942014 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125514 1 2 1152015 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 0 1 1192001 74 MCG ( 74 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SYLATRON

Proper Name PEGINTERFERON ALFA-2B

March 2018 Page 30 of 42

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name ZINPLAVA

Proper Name BEZLOTOXUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761046 0 1 10212016 1000 MG40 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830

Trade Name XEOMIN

Proper Name INCOBOTULINUMTOXINA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125360 0 1 7302010

POWDER INTRAMUSCULAR

50 U ( 50 UVIAL )

SINGLE-DOSE VIAL

125360 0 2 7302010

POWDER INTRAMUSCULAR

100 U ( 100 UVIAL )

SINGLE-DOSE VIAL

125360 3 3 11202015

POWDER INTRAMUSCULAR

200 U ( 200 UVIAL )

SINGLE-DOSE VIAL

March 2018 Page 31 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

Trade Name ARZERRA

Proper Name OFATUMUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125326 0 1 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

100 MG5 ML ( 20 MGML )

125326 0 2 10262009

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

1000 MG50 ML ( 20 MGML )

Trade Name

Proper Name

BLASTN

125504 0

COSENTYX

SECUKINUMAB

Approval Date Product

1212015 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

150 MG ( 150 MGVIAL )

125504 0 2 1212015

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MGML ( 150 MGML )

125504 0 3 1212015

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MGML ( 150 MGML )

Trade Name

Proper Name

BLASTN

125290 0

EXTAVIA

INTERFERON BETA-1B

Approval Date Product

8142009 1

PotencyDosage FormRoutePresentation

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

03 MG ( 03 MGVIAL )

Trade Name

Proper Name

BLASTN

125319 0

ILARIS

CANAKINUMAB

Approval Date Product

6172009 1

PotencyDosage FormRoutePresentation

180 MGVIAL ( 180 MGVIAL )

March 2018 Page 32 of 42

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244

125319 88 2 12222016 150 MG ( 150 MGVIAL )

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

125319 0 3 12222016 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name SIMULECT

Proper Name BASILIXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103764 0 1 5121998 10 MG ( 10 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

103764 0 2 5121998 20 MG ( 20 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No NPS PHARMACEUTICALS INC 1908

Trade Name NATPARA

Proper Name PARATHYROID HORMONE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )

POWDER SUBCUTANEOUS AUTOINJECTOR

March 2018 Page 33 of 42

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No PROMETHEUS LABORATORIES INC 1848

Trade Name PROLEUKIN

Proper Name ALDESLEUKIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103293 0 1 551992 22 MIU ( 22 MIUVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760

Trade Name ARCALYST

Proper Name RILONACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125249 0 1 2272008

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

220MG ( 220MGVIAL )

Trade Name

Proper Name

DUPIXENT

DUPILUMAB

BLASTN

761055 0

Product

1

Approval Date

3282017

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

300 MG2 ML ( 150 MGML )

Trade Name

Proper Name

EYLEA

AFLIBERCEPT

BLASTN

125387 0

Product

1

Approval Date

11182011

PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

2 MG005 ML ( 40 MGML )

March 2018 Page 34 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Trade Name ELITEK

Proper Name RASBURICASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103946 0 1 7122002

POWDER INTRAVENOUS SINGLE-DOSE VIAL

15 MG ( 15 MGVIAL )

103946 5020 2 162006

POWDER INTRAVENOUS SINGLE-DOSE VIAL

75 MG ( 75 MGVIAL )

Trade Name

Proper Name

BLASTN

761037 0

KEVZARA

SARILUMAB

Approval Date Product

5222017 1

PotencyDosage FormRoutePresentation

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

150 MG114 ML ( 13158 MGML )

761037 0 2 5222017

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MG114 ML ( 17544 MGML )

761037 1 3 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

150 MG114 ML ( 13158 MGML )

761037 1 4 4132018

SOLUTION SUBCUTANEOUS AUTOINJECTOR

200 MG114 ML ( 17544 MGML )

Trade Name

Proper Name

BLASTN

103362 0

LEUKINE

SARGRAMOSTIM

Approval Date Product

351991 1

PotencyDosage FormRoutePresentation

POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

250 MCG ( 250 MCGVIAL )

103362 0 2 351991

SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL

500 MCGML ( 500 MCGML )

Trade Name PRALUENT

March 2018 Page 35 of 42

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No SANOFI AVENTIS US LLC 1752

Proper Name ALIROCUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125559 0 1 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 2 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

125559 0 3 7242015 75 MGML ( 75 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

125559 0 4 7242015 150 MGML ( 150 MGML )

SOLUTION SUBCUTANEOUS AUTOINJECTOR

Trade Name ZALTRAP

Proper Name ZIV-AFLIBERCEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125418 0 1 832012 100 MG4 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125418 0 2 832012 200 MG8 ML ( 25 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SEATTLE GENETICS INC 1853

Trade Name ADCETRIS

Proper Name BRENTUXIMAB VEDOTIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125388 1 1 8192011 50 MG ( 50 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 36 of 42

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593

Trade Name ELAPRASE

Proper Name IDURSULFASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125151 0 1 7242006 6 MG3 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SICOR BIOTECH UAB 1803

Trade Name GRANIX

Proper Name TBO-FILGRASTIM

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125294 0 1 8292012

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

300 MCG0 5 ML ( 600 MCGML )

125294 0 2 8292012

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

480 MCG08 ML ( 600 MCGML )

ApplicantLicense No SMITH AND NEPHEW INC 2004

Trade Name REGRANEX

Proper Name BECAPLERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103691 0 1 12161997

GEL TOPICAL

100 UG ( 100 UGGM )

Trade Name

Proper Name

SANTYL

COLLAGENASE

BLASTN

101995 0

Product

1

Approval Date

641965

PotencyDosage FormRoutePresentation

OINTMENT TOPICAL

30 G amp 90 G TUBE ( 250 UGRAM )

March 2018 Page 37 of 42

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718

Trade Name MYOBLOC

Proper Name RIMABOTULINUM TOXIN B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

103846 0 1 1282002

SOLUTION INTRAMUSCULAR

2500 IU05 ML ( 5000 IUML )

SINGLE-DOSE VIAL

103846 0 3 1282002

SOLUTION INTRAMUSCULAR

10000 IU2 ML ( 5000 IUML )

SINGLE-DOSE VIAL

Proper Name RIMABOTULINUMTOXINB

BLASTN

103846 0

Product

2

Approval Date

1282002

PotencyDosage FormRoutePresentation

SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL

5000 IUML ( 5000 IUML )

ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832

Trade Name ZEVALIN

Proper Name IBRITUMOMAB TIUXETAN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125019 0 1 2192002 32 MG2 ML ( 16 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

Trade Name KEPIVANCE

Proper Name PALIFERMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125103 0 1 12152004 625 MG ( 625 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

Trade Name KINERET

Proper Name ANAKINRA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

March 2018 Page 38 of 42

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828

103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898

Trade Name ENTYVIO

Proper Name VEDOLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125476 0 1 5202014 300 MG ( 300 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No TEVA RESPIRATORY LLC 2047

Trade Name CINQAIR

Proper Name RESLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761033 0 1 3232016 100 MG10 ML ( 10 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No THERATECHNOLOGIES INC 2091

Trade Name TROGARZO

Proper Name IBALIZUMAB-UIYK

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761065 0 1 362018 200 MG133 ML ( 150 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 39 of 42

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

SOLUTION INTRAVITREAL SINGLE-DOSE VIAL

0375 MG03 ML ( 125 MGML )2222017 125422 038 1

ApplicantLicense No UCB INC 1736

Trade Name CIMZIA

Proper Name CERTOLIZUMAB PEGOL

BLASTN Approval Date PotencyDosage FormRoutePresentation Product

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

200 MG ( 200 MGVIAL ) 4222008 125160 0 1

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

200 MGML ( 200 MGML )5132009 125160 080 2

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

Trade Name CRYSVITA

Proper Name BUROSUMAB-TWZA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761068 0 1 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

10 MGML ( 10 MGML )

761068 0 2 4172018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

20 MGML ( 20 MGML )

761068 0

Trade Name

Proper Name

BLASTN

March 2018

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

30 MGML ( 30 MGML ) 4172018 3

MEPSEVII

VESTRONIDASE ALFA-VJBK

Approval Date PotencyDosage FormRoutePresentation Product

Page 40 of 42

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040

761047 0 1 11152017 10 MG5 ML ( 2 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No UNITED THERAPEUTICS CORP 1993

Trade Name UNITUXIN

Proper Name DINUTUXIMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125516 0 1 3102015 175 MG5 ML ( 35 MGML )

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053

Trade Name SILIQ

Proper Name BRODALUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761032 0 1 2152017 210 MG15 ML ( 140 MGML )

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 41 of 42

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Billable Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

ApplicantLicense No WYETH PHARMACEUTICALS INC 0003

Trade Name BESPONSA

Proper Name INOTUZUMAB OZOGAMICIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation

761040 0 1 8172017 09 MG ( 09 MGVIAL )

POWDER INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 42 of 42

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

March 2018 Page 1 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No AMGEN INC 1080

Trade Name ARANESP

9172001 103951 0 26

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

200 MCGML ( 200 MCGML ) 09272012

103951 0 27 9172001

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

200 MCG04 ML ( 500 MCGML ) 09272012

103951 0 28 9172001

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

300 MCGML ( 300 MCGML ) 09272012

103951 0 29 9172001

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

300 MCG06 ML ( 500 MCGML ) 09272012

103951 0 30 9172001

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

500 MCGML ( 500 MCGML ) 09272012

ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748

Trade Name AMEVIVE

Proper Name ALEFACEPT

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251

Trade Name VERLUMA

Proper Name NOFETUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013

INTRAVENOUS

March 2018 Page 2 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824

Trade Name ORTHOCLONE OKT3

Proper Name MUROMONAB-CD3

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012

SOLUTION INTRAVENOUS AMPULE

ApplicantLicense No EISAI INCORPORATED 1862

Trade Name ONTAK

Proper Name DENILEUKIN DIFTITOX

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1611

Trade Name XIGRIS

Proper Name DROTRECOGIN ALFA (ACTIVATED)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GENENTECH INC 1048

Trade Name RAPTIVA

Proper Name EFALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

March 2018 Page 3 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name MYOZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name BEXXAR THERAPEUTIC REGIME

Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703

Trade Name ALFERON N INJECTION

Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013

SOLUTION INTRALESIONAL MULTI-DOSE VIAL

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name ROFERON A

Proper Name INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name ZENAPAX

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867

Trade Name INFERGEN

Proper Name INTERFERON ALFACON-1

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 5 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name INTRON A

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

March 2018 Page 6 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name PEGINTRON

103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No PALATIN TECHNOLOGIES INC 1588

Trade Name NEUTROSPEC TECHNETIUM (99M TC)

Proper Name FANOLESOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No RECORDATI RARE DISEASES INC 1899

Trade Name ELSPAR

Proper Name ASPARAGINASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

March 2018 Page 7 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824

Trade Name ORTHOCLONE OKT3

Proper Name MUROMONAB-CD3

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012

SOLUTION INTRAVENOUS AMPULE

ApplicantLicense No EISAI INCORPORATED 1862

Trade Name ONTAK

Proper Name DENILEUKIN DIFTITOX

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No ELI LILLY AND CO 1611

Trade Name XIGRIS

Proper Name DROTRECOGIN ALFA (ACTIVATED)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GENENTECH INC 1048

Trade Name RAPTIVA

Proper Name EFALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

Trade Name XOLAIR

March 2018 Page 3 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name MYOZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name BEXXAR THERAPEUTIC REGIME

Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703

Trade Name ALFERON N INJECTION

Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013

SOLUTION INTRALESIONAL MULTI-DOSE VIAL

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name ROFERON A

Proper Name INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name ZENAPAX

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867

Trade Name INFERGEN

Proper Name INTERFERON ALFACON-1

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 5 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name INTRON A

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

March 2018 Page 6 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name PEGINTRON

103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No PALATIN TECHNOLOGIES INC 1588

Trade Name NEUTROSPEC TECHNETIUM (99M TC)

Proper Name FANOLESOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No RECORDATI RARE DISEASES INC 1899

Trade Name ELSPAR

Proper Name ASPARAGINASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

March 2018 Page 7 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No GENENTECH INC 1048

Trade Name XOLAIR

Proper Name OMALIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No GENZYME CORP 1596

Trade Name CAMPATH

Proper Name ALEMTUZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

Trade Name MYOZYME

Proper Name ALGLUCOSIDASE ALFA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No GLAXOSMITHKLINE LLC 1727

Trade Name BEXXAR THERAPEUTIC REGIME

Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

March 2018 Page 4 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703

Trade Name ALFERON N INJECTION

Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013

SOLUTION INTRALESIONAL MULTI-DOSE VIAL

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name ROFERON A

Proper Name INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name ZENAPAX

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867

Trade Name INFERGEN

Proper Name INTERFERON ALFACON-1

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 5 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name INTRON A

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

March 2018 Page 6 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name PEGINTRON

103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No PALATIN TECHNOLOGIES INC 1588

Trade Name NEUTROSPEC TECHNETIUM (99M TC)

Proper Name FANOLESOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No RECORDATI RARE DISEASES INC 1899

Trade Name ELSPAR

Proper Name ASPARAGINASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

March 2018 Page 7 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703

Trade Name ALFERON N INJECTION

Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013

SOLUTION INTRALESIONAL MULTI-DOSE VIAL

ApplicantLicense No HOFFMANN LA ROCHE INC 0136

Trade Name ROFERON A

Proper Name INTERFERON ALFA-2A

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009

SOLUTION SUBCUTANEOUS PREFILLED SYRINGE

Trade Name ZENAPAX

Proper Name DACLIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011

SOLUTION INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867

Trade Name INFERGEN

Proper Name INTERFERON ALFACON-1

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013

SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 5 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name INTRON A

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

March 2018 Page 6 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name PEGINTRON

103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No PALATIN TECHNOLOGIES INC 1588

Trade Name NEUTROSPEC TECHNETIUM (99M TC)

Proper Name FANOLESOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No RECORDATI RARE DISEASES INC 1899

Trade Name ELSPAR

Proper Name ASPARAGINASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

March 2018 Page 7 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MEDIMMUNE LLC 1799

Trade Name SYNAGIS

Proper Name PALIVIZUMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007

POWDER INTRAMUSCULAR SINGLE-DOSE VIAL

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name INTRON A

Proper Name INTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013

SOLUTION SUBCUTANEOUS PREFILLED PEN

Trade Name PEGINTRON

Proper Name PEGINTERFERON ALFA-2B

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

March 2018 Page 6 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name PEGINTRON

103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No PALATIN TECHNOLOGIES INC 1588

Trade Name NEUTROSPEC TECHNETIUM (99M TC)

Proper Name FANOLESOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No RECORDATI RARE DISEASES INC 1899

Trade Name ELSPAR

Proper Name ASPARAGINASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

March 2018 Page 7 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002

Trade Name PEGINTRON

103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016

POWDER SUBCUTANEOUS PREFILLED PEN

103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016

POWDER SUBCUTANEOUS SINGLE-DOSE VIAL

ApplicantLicense No PALATIN TECHNOLOGIES INC 1588

Trade Name NEUTROSPEC TECHNETIUM (99M TC)

Proper Name FANOLESOMAB

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008

POWDER INTRAVENOUS SINGLE-DOSE VIAL

ApplicantLicense No RECORDATI RARE DISEASES INC 1899

Trade Name ELSPAR

Proper Name ASPARAGINASE

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014

POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL

March 2018 Page 7 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No SCHERING CORP 0994

Trade Name PEGINTRONREBETOL COMBO PACK

Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL

ApplicantLicense No THROMBOGENICS INC 1866

Trade Name JETREA

Proper Name OCRIPLASMIN

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125422 0 2 10172012 05 MG ( 25 MGML ) 08082017

SOLUTION INTRAVETREAL SINGLE-DOSE VIAL

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA

BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List

125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 8 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9

CDER Discontinued Biologic Product List

ApplicantLicense No VIFOR INTERNATIONAL AG 2039

Trade Name MIRCERA

125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE

125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008

SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL

March 2018 Page 9 of 9