A Milestone in Facilitating the Development of Safe and Effective Biosimilars

The Biologics Price Competition and Innovation Act of 2009 created a pathway for the U.S. Food and Drug Administration to approve biosimilars. A biosimilar is a biological product (biologic) that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic (also called the reference product). Biologics are some of the most expensive treatments in the U.S., and approving biosimilars can enhance competition, drive down costs to health care systems, and increase patient access to biologic therapies.

This week, the FDA approved the 50^th biosimilar, reflecting the markedly increased availability of biosimilar products—products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access. Biosimilars are now approved for 15 different reference biologics, and treat illnesses like rheumatoid arthritis, inflammatory bowel disease, some cancers, psoriasis, diabetes, macular degeneration, osteoporosis, and more.

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