FDA to Unveil Biosimilars Action Plan (BAP)

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 regulatory certainty for biosimilar manufacturers and other stakeholders.” According to Dr. Gottlieb, the BAP “will include elements like enhancing our education campaign for [healthcare providers] and patients …, reducing gaming that may delay market competition, strengthening int’l regulatory partnerships and providing clarity for product developers via guidance and meetings.” The BAP “will advance [the FDA’s] goals” “to facilitate efficient development, approval of biosimilars to reduce costs, enhance access, without reducing incentives to innovate.”

In connection with FDA’s rollout of the BAP, Dr. Gottlieb stated that he was looking forward to speaking at a July 18th event at the Brookings Institute in Washington, DC to discuss the BAP, as well as the FDA’s “new efforts to cultivate a vibrant U.S. market for biosimilars and other efforts to enhance competition and reduce drug costs.”

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