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Event Title
Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)
December 3, 2025

Date:
December 3, 2025
Time:
9:00 a.m. - 12:00 p.m. ET

On December 3, 2025, the Food and Drug Administration (FDA or Agency) held a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years.

The purpose of this public meeting was to hear the public’s views on BsUFA as we consider elements to propose, update, or discontinue in the next BsUFA. The FDA also solicited responses to the following general questions:

  • What is your assessment of the overall performance of the current reauthorization of BsUFA FY 2023 through 2027 to date?
  • What current elements of BsUFA should be retained, changed or discontinued to further strengthen and improve the program?
  • What new elements, if any, should FDA consider adding to the program to enhance the efficiency and effectiveness of the biosimilar biological product review process?
  • What changes, if any, could be made to the current fee structures and amounts to be better advance the goals of the agreement, including facilitating product development and timely access for consumers?

For more background information on the meeting, please see the Federal Register Notice with assigned docket FDA-2015-N-3326. To provide a public comment, please visit the public docket. The public docket closes on January 2, 2026.

The meeting recording and transcript will be posted to this page as they become available.

Meeting Recording

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