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  1. Biosimilar User Fee Amendments

BsUFA III: Fiscal Years 2023-2027

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the second reauthorization of the Biosimilar User Fee Act (BsUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for biosimilar biological products.

FDA developed the proposed enhancements for BsUFA III in consultation with drug industry representatives from March 2021 through June 2021. FDA also consulted with public stakeholders via two public meetings and associated public comment requests. FDA transmitted these proposed enhancements to Congress in January 2022, which are referred to in Title IV of the FDA User Fee Reauthorization Act.

The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2023-2027. FDA dedicates this funding to expediting the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public. This page contains the relevant information related to BsUFA III and FDA’s implementation of the BsUFA III enhancements. It also includes information related to the negotiations and consultations prior to the agreement.

Implementation

BsUFA III Commitment Letter

BsUFA III Reauthorization Proposed Enhancements Public Meeting - November 2, 2021

FDA is announcing a virtual public meeting to discuss the proposed enhancements for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Meeting Information

BsUFA III Reauthorization Kickoff Public Meeting - November 19, 2020

FDA held a virtual public meeting on November 19, 2020 to kick off the process for reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Meeting Information

Industry Discussions on Reauthorization

 

 
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