Public Meeting on the Reauthorization of BsUFA

The Food and Drug Administration (FDA or Agency) is announcing a hybrid public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. BsUFA authorizes FDA to collect user fees to support the process of 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.

This meeting will also provide an opportunity for public comment. All requests to make a public comment during the meeting must be received via registration by November 14, 11:59 p.m. Eastern Time.

As they become available, additional information (e.g. the Federal Register notice, the meeting agenda) will be provided here: https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025

In- Person Location: FDA 10903 New Hampshire Avenue Great Room (Enter at Building 1 to clear security) Silver Spring, MD 20903. For information on parking, please view the Visitor Parking and Campus Map.

Webinar Location: Microsoft Teams