FDA-TRACK: Biosimilar User Fee Act Procedural Notifications

 

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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 Notifications Dataset

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Footnotes:

• * FY 2025 and FY 2026 includes preliminary performance as of 12/31/2025.
• ** New Performance Goal for BsUFA III (see Changes for this Goal, page 5).