BIOSIMILARSWHAT IS A BIOSIMILAR?

A BIOSIMILAR IS NOT A GENERIC.

BIOLOGICS, INCLUDING BIOSIMILARS, ARE USED FOR THE TREATMENT OF MANY COMPLEX DISEASES.2

A demonstration of similarity signifies that while not identical, any difference in quality attributes should have no adverse impact upon safety or

efficacy of the biosimilars.2

CANCER

PSORIASIS

CROHN’S DISEASE

DIABETES

GROWTH DEFICIENCIES

RHEUMATOID ARTHRITIS

Generic drugs are chemically synthesized, small-molecule products. They contain identical medicinal ingredients to their brand name reference product.1

BIOSIMILARS ARE DIFFERENT. A biosimilar is a subsequent entry version of a biologic drug that enters the market after the innovator biologic and with a demonstrated similarity to the innovator biologic.2

Biologic drugs are generally larger and more complex than chemically produced pharmaceutical drugs and are made from living cells.1

Due to these qualities and the natural variability of biologic drugs, a biosimilar and its reference biologic drug can be shown to be similar, but not identical.1

BIOLOGICGENERIC

Biologics sales growth MORE THAN DOUBLED total drug expenditures

• Biologics: 9.7% compared to 3.6% for total drug expenditures3*†

* Clinical signi�cance unknown.† For the 12 months ending December 2016.

ONE OF CANADA’S FASTEST GROWING SEGMENTS IN PHARMACEUTICAL SPENDING3*†ONE OF CANADA’S FASTEST GROWING SEGMENTS IN BIOLOGICS:

BIOLOGICS REPRESENTED IN CANADA:3*†

Biologics sales growthIN 2016:

DID YOU KNOW?In 2016, biologic medicines accounted for $6.9 billion in sales in Canada3*†

• 34% of total brand prescription sales in dollars Includes 7 out of the top 10 pharmaceutical brands

34%

References:

1. Health Canada. Drug and Health Products Fact Sheet: Biosimilars. Modi�ed December 07, 2016. Available online: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/biosimilars-biosimilaires- qa-qr-eng.pdf.

2. Health Canada. Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Revised November 14, 2016. Available online: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/ applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf

3. Quintiles IMS, PharmaFocus 2020, MAT December 2016. (Accessed February 2017)

© 2017 Merck Canada Inc. All rights reserved.BIOS-1177558-0002 MA 2018