FDA-TRACK: Biosimilar User Fee Act Biosimilar Applications and Supplements

 

 

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Biosimilar Applications and Supplements

Procedural Notifications

Procedural Responses

Meeting
Management

• • Current Performance
• • Historical Performance

• • Current Performance
• • Historical Performance

• • Current Performance
• • Historical Performance

• • Current Performance
• • Historical Performance

Relevant Links:

1. • BsUFA III Commitment Letter
2. • Biosimilar User Fee Amendments
3. • Biosimilar Definitions
4. • BsUFA Reauthorization Act
5. • 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 Biosimilar Applications and Supplements Dataset

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Footnotes:

• * Performance is currently preliminary due to pending submissions.
• ** New Performance Goal for BsUFA III (see Changes for this Goal, pages 4-7).