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Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, "Advancing the Development of Interchangeable Products: Identifying Future Needs," held on September 19, 2025, and to describe FDA's future directions to support interchangeable biosimilar products. FDA is issuing this draft Strategy Document to fulfill a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 through 2027 (BsUFA III) to publish a post-workshop draft strategy document for public comment.
- Document type
- Notice
- Federal Register document number
- 2026-19166
- Published
- Sep 18, 2026
- Action
- Notice of availability.
- Docket
- FDA-2025-N-2787
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on this draft Strategy Document by November 17, 2026 to ensure that the Agency considers your comment on this draft Strategy Document before it begins work on the final version of the Strategy Document.
- Topics (auto-tagged)
- Vaccines / biologics
Source: Federal Register API, document 2026-19166. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.