Federal Register #FDA-2026-N-7707

FDA Announces Biosimilar User Fee Rates for Fiscal Year 2027

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is announcing the biosimilar user fee rates for fiscal year 2027 under the Biosimilar User Fee Amendments of 2022 (BsUFA III). - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEM Highlight: - FDA is the regulatory authority responsible for collecting biosimilar user fees - Products/Services Requested: - Initial Biosimilar Product Development (BPD) Fee: 36 units at $10,000 each - Annual Biosimilar Product Development (BPD) Fee: 142 units at $10,000 each - Reactivation Fee: 0 units at $20,000 each (fee available if needed) - Biosimilar Biological Product Application Fee (requiring clinical data): 19 units at $1,124,936 each - Biosimilar Biological Product Application Fee (not requiring clinical data): 0 units at $562,468 each (fee available if needed) - Biosimilar Biological Product Program Fee: 194 units at $195,887 each - Notable Requirements: - Fees apply to biosimilar product development, application review, and program maintenance - Fee waivers and refund policies are available, including for small businesses - No specific commercial products or part numbers are listed, as this is a regulatory fee schedule - Estimated quantities for each fee type are provided for planning purposes

Description

The Food and Drug Administration (FDA) announces the biosimilar user fee rates for fiscal year 2027 as authorized by the Biosimilar User Fee Amendments of 2022 (BsUFA III). These fees support activities related to biosimilar biological product development, review of biosimilar product applications, and approved biosimilar products. The fee schedule includes initial and annual biosimilar biological product development fees, reactivation fees, application fees for products requiring or not requiring clinical data, and program fees. These fees apply from October 1, 2026, through September 30, 2027, and are effective for applications submitted on or after October 1, 2026.

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