The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.
US Federal Register - FDA Notices · July 30, 2026
Biosimilar User Fee Rates for Fiscal Year 2027
FDA announces biosimilar user fee rates for FY 2027 under the Biosimilar User Fee Amendments of 2022.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.