Federal Register #FDA-2026-N-0007

FDA Announces FY 2027 Prescription Drug and Biosimilar User Fee Rates

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has published the official user fee rates for prescription drug and biosimilar product applications for Fiscal Year 2027. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - No specific OEMs or vendors are named; fees apply to all entities submitting qualifying applications. - Products/Services Requested: - Prescription drug application review (with and without clinical data) - $4,600,753 per application requiring clinical data - $2,300,376 per application not requiring clinical data - Prescription drug program fee: $416,857 per approved product (estimated 2,875 program fees invoiced) - Biosimilar biological product development and application fees: - Initial biosimilar development fee: $10,000 - Annual biosimilar development fee: $10,000 - Reactivation fee: $20,000 - Biosimilar application fee (with clinical data): $1,124,936 - Biosimilar application fee (without clinical data): $562,468 - Biosimilar program fee: $195,887 per approved product - Unique/Notable Requirements: - Fees are statutory and apply to all qualifying prescription drug and biosimilar applications submitted to the FDA - No product-specific or vendor-specific requirements; applies industry-wide - Fee waivers and payment procedures are outlined in the notice

Description

The Food and Drug Administration (FDA) announces the prescription drug user fee rates for fiscal year 2027, applicable from October 1, 2026, through September 30, 2027. These fees are authorized under the Federal Food, Drug, and Cosmetic Act as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII). The notice establishes application fees for the review of human drug and biological products and prescription drug program fees for certain approved products. The fee rates include amounts for applications requiring covered clinical data, applications not requiring such data, and prescription drug program fees.

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