The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established a pathway for the U.S. to approval biosimilars, which are highly similar to FDA-approved biologics with no clinically meaningful differences. Biologics are expensive treatments, and FDA biosimilar approval can promote competition, lower costs, and increase patient access to therapies. The recent approval of the 50th biosimilar by the FDA indicates a significant increase in biosimilar availability, benefiting patients with various chronic and severe illnesses such as rheumatoid arthritis, cancer, diabetes, and more. Biosimilars are now approved for 15 different reference biologics, demonstrating their growing impact on healthcare access.1

You can read more about the FDA’s approval of the 50th biosimilar here.

References

  1. Office of the Commissioner. (2024, April 26). A milestone in facilitating the development of safe and effective biosimilars. U.S. Food And Drug Administration. https://www.fda.gov/news-events/fda-voices/milestone-facilitating-development-safe-and-effective-biosimilars

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