Biosimilars Action Plan (BAP)

FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access…

In a series of tweets on July 8, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that the FDA “will soon unveil a comprehensive Biosimilars Action Plan (BAP) that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase…

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FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

FDA to Unveil Biosimilars Action Plan (BAP)