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 III Commitment Letter

• BsUFA III Commitment Letter (PDF - 205 KB)

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

• June 4, 2021: Steering Committee (PDF - 142 KB)
• June 1, 2021: Steering Committee (PDF - 129 KB)
• May 25, 2021: Steering Committee (PDF - 141 KB)
• May 19, 2021: Steering Committee (PDF - 129 KB)
• May 11, 2021: Steering Committee (PDF -  131 KB)
• May 4, 2021: Steering Committee (PDF - 132 KB)
• April 27, 2021: Steering Committee (PDF - 132 KB)
• April 20, 2021: Steering Committee (PDF - 132 KB)
• April 13, 2021: Steering Committee (PDF - 132 KB)
• April 6, 2021: Steering Committee (PDF - 134 KB)
• March 30, 2021: Steering Committee (PDF - 134 KB)
• March 23, 2021: Steering Committee (PDF - 156 KB)
• March 16, 2021: Steering Committee (PDF - 159 KB)