FDA-TRACK: Biosimilar User Fee Act Procedural Responses

 

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Biosimilar Applications and Supplements

Procedural Notifications

Procedural Responses

Meeting
Management

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

Relevant Links:

1. • BsUFA III Commitment Letter
2. • Biosimilar User Fee Amendments
3. • Biosimilar Definitions
4. • BsUFA Reauthorization Act
5. • FDA-TRACK: BsUFA Performance Reports
6. • FDA-TRACK: CDER Biosimilars Dashboard

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

Download BsUFA Procedural Responses Dataset

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Footnotes:

• * FY 2025 and FY 2026 include preliminary performance as of 3/31/2026.
• †† Major Dispute Resolution data is only available on an annual basis.
• ‡ Includes resubmitted Special Protocol Assessments, if applicable.
• ** New Performance Goal for BsUFA III with performance tracking beginning in FY 2023 (see Changes for this Goal, page 28).
• *** New Performance Goal for BsUFA III with performance tracking beginning in FY 2024 (see Changes for this Goal, page 27).