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 by October 31, 2025, approximately midway through the pilot program.
FDA will host a hybrid in-person/virtual meeting to meet the BsUFA III Commitment on September 18, 2025.
As they become available, additional information (e.g. the Federal Register notice, meeting materials) will be provided at the link: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-bsufa-iii-regulatory-science-program-interim-public-meeting-09182025
Visitor information for in person attendance:
https://www.fda.gov/about-fda/visitor-information
