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  1. Biosimilar User Fee Amendments

BsUFA III: Fiscal Years 2023-2027

In August 2017, the FDA Reauthorization Act of 2017 (FDARA) was enacted, which renewed the biosimilar user fee program (BsUFA) for a second time. The current legislative authority for BsUFA II expires in September 2022. At that time, new legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years.

Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.

BsUFA Public Meeting November 19, 2020

FDA held a public meeting to discuss proposed recommendations for the reauthorization of BsUFA for fiscal years 2023 through 2027 on November 19, 2020. Meeting Information

Industry Discussions on Reauthorization

 

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