apotheke, prof. dr. i. krämer how to evaluate a biosmilar from a · advantages/disadvantages of...

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Apotheke, Prof. Dr. I. Krämer

University Medical Center

Department of Pharmacy, Prof. Dr. Irene Krämer

How to evaluate a biosmilar

from a

hospital pharmacist‘s perspective


Irene Krämer

is/has been advisory board member for Amgen

and Sanofi and speaker sponsored by Roche and

Sanofi.

Disclosure

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Individual positive list of medication routinely stocked

and used in the hospital

Selected by the pharmacy and therapeutics committee

Including guidelines for optimal medication use

Approved guidelines for substitution (aut idem) and

therapeutic interchange (aut simile) in the hospital

Biosimilars and the hospitals’ formulary

Aut simile

Interchange

Aut idem

Substitution

Aut simile

InterchangeAut simile

Interchange

Medicinal

product

Chemical

Medicinal

product

Biopharma-

ceutical

Mee too Generic

New

chemical

medicinal

product

Mee too

New

Biopharma-

ceuticalBiosimilar

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Substitution of Bioidenticals

Automatic

Substitution

Inflectra®, Infliximab

CT-P13, Hospira

Biosimilar to Remicade®

Remsima®, Infliximab

CT-P13, Celltrion

Biosimilar to Remicade®

Remicade®, Infliximab

Originator product

co-marketed bioidenticals


Quality

Clinical Efficacy

Safety/Tolerability/Pharmacovigilance

Interchangeability/Substitution

Cost effectiveness

Krämer, Tredee, Vulto EJHPP 2008; 14: 73-6

Evaluation of Biosimilars Points to consider from a pharmacist’s perspective

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Adapted from: 22Krämer et al. EJHP Practice 2008:14;73–76

Clinical safety: Pharmacovigilance

• Are there any safety-related post-

marketing commitments?

• What (short- and long-term) risk

management programmes are in place?

• When clinically indicated, does the

company support antibody testing in

patients?

• Tabulated summaries from

supplier

• EMEA/FDA reports

CIB

• ‘Dear Pharmacist’ letters

• Bibliographies by the

manufacturer

• National databases

• Company data-on-file

• National official information

systems

POSSIBLE RESOURCESASPECTS TO CONSIDER


From the checklist to the matrix system

Decision matrix: biosimilar versus originator product

Ten selection criteria were judged as relevant for clinical practice

MD and pharmacist can give own weight to criteria

Boone et al Eur J Hosp Pharm 2013

. Boone N et al. Eur J Hosp Pharm. 2013;20:275-286. doi:10.1136/ejhpharm-2013-000370.

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Prequalification criteria

Reliability of supply (cave: drug shortages)

Medical support available 24 hours/7 days a week

Medication safety aspects: ensured traceability

Suitable labels for documentation of batch numbers in

patient records

Financial and insurance criteria (reimbursement policies)

Price

Example of Biosimilar Judgement

adopted from N. Boone

Criterion Originator Biosimilar Relative Weight

1. Biological experience manufacturer

100% (10%/year) 60% 3%

2. How long on the market?

100% (25%/year) 100% 3%

3. Clinical experience 100% (10%/million patient days)

40% 3%

4. Formulation, ease of administration

100% (20%/strength), ready to use (= 40%) + vial for safe

dosing in children (+20%)

80% (2 strengths) + RTU

5%

5. Number of approved indications

100% (4 indications, 25%/indication)

100% 3%

RTU: ready-to-use.Boone N et al. Eur J Hosp Pharm. 2013;20:275-286. doi:10.1136/ejhpharm-2013-000370.EMA Web site. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000917/human_med_001170.jsp&mid=WC0b01ac058001d124.

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SPC: Summary of Product Characteristics.Boone N et al. Eur J Hosp Pharm. 2013;20:275-286. doi:10.1136/ejhpharm-2013-000370.EMA Web site. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000917/human_med_001170.jsp&mid=WC0b01ac058001d124..

Example of Biosimilar Judgement

adopted from N. Boone

Criterion Originator Biosimilar Relative Weight

6. Clinical efficacy 100%; large amount of data

100%; extrapolation data reference product

25%

7. Safety and tolerability

100%; large amount of data

100%; extrapolation data reference product

25%

8. Special precautions, CIs

100%: SPC data 100%: if SPC identical to originator; same score

5%

9. Immunogenicity 100%: depends on available data

100%: depends on available data

25%

10. Drug interactions 100%: SPC data 100%: if SPC identical to originator; same score

3%


Advantages/Disadvantages of matrix scores

Objectification of decision making

Rational selection by P&T committees in hospitals

Quality aspects – not only costs

Selection matrices for specific groups of biosimilars

necessary

Effort to implement expert knowledge

Additional effort for registries/phase IV studies not regarded

Additional costs for exchange, e.g. education not regarded

Difference between treatment naïve/adapted patients,

single/multiple switching not regarded

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Biosimilar or Bioidentical?

apotheke, prof. dr. i. krämer how to evaluate a biosmilar from a · advantages/disadvantages of...

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