💵FDA Announces Biosimilar User Fee Rates for FY 2026
Biosimilar User Fee Rates for Fiscal Year 2026
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2026. 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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document outlines new biosimilar user fees, which directly impact businesses developing and approving biosimilar products. Firms must budget for initial and annual fees, reactivation fees, and application fees, affecting their financial planning and operational costs associated with product development and regulatory compliance.