Biosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Interim Report; Availability; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Biosimilar User Fee Act (BsUFA) III Regulatory Science Program Interim Public Meeting" and the availability of the report entitled "BsUFA III Regulatory Science Pilot Program Interim Report." The purpose of the public meeting is to review the progress of the BsUFA III Regulatory Science Program aims, or demonstration projects, and to solicit input on future research priorities. Under the BsUFA reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III), FDA committed to piloting a regulatory science program to facilitate biosimilar and interchangeable product development that focuses on: (1) advancing the development of interchangeable products; and (2) improving the efficiency of biosimilar product development. The purpose of the interim progress report is to provide a summary of activities that established the pilot program, an overview of research progress, and a brief discussion of future directions.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.