- Date:
- September 18, 2025
- Time:
- 9:00 a.m. - 3:00 p.m. ET
Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA committed to piloting a regulatory science program that focuses on: 1) advancing the development of interchangeable products; and 2) improving the efficiency of biosimilar product development. For stakeholder engagement, this commitment includes publishing an interim progress report and holding an interim public meeting approximately midway through the pilot program.
The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.
The meeting agenda includes an overview of the regulatory science program, presentations by internal and external awardees conducting research projects under the BsUFA III regulatory science program, and panel discussions by FDA staff and representatives from the biosimilar industry.
The Federal Register Notice, additional materials, and any other updates will also be posted to this website as they become available.
Event Materials: Agenda
