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 for the review of biosimilar biological product applications. 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. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations FDA also invites public comment as the Agency continues the process to reauthorize the program in FYs 2028 - 2032. The comment period will close November 25, 2026.

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 October 16, 11:59 p.m. Eastern Time.

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