comprehensive

Biosimilars are no longer a new and untested class of medicines. Today, they provide critical treatment options across multiple therapeutic areas. Since the Biologics Price Competition and Innovation Act of 2009 created a regulatory pathway for biosimilar medicine review in the U.S., 37 biosimilars have come to market offering the potential to increase patient choice and cost savings. And according to the 2023 analysis from IQVIA, biosimilars are expected to generate $181 billion in savings for the U.S. health care system over the next five years.

This progress is due, in part, to thoughtfully considered, scientifically robust regulatory standards, which have instilled confidence among health care providers and patients while protecting safety. As a former associate director of therapeutic biologics at the Food and Drug Administration, I had the privilege of helping create and lead implementation of the regulatory framework for biosimilars. The FDA took great care to apply appropriate scientific rigor to the development and approval standards. While I have since moved to Amgen, my goals have remained focused on biosimilar product quality and efficacy, patient safety, and prescriber confidence.

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More than a decade later, collective efforts by biosimilar manufacturers and the FDA are paying off.

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