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# BsUFA Regulatory Research Roadmap
- URL: https://www.fdaweb.com/bsufa-regulatory-research-roadmap/
- Published: 2023-01-25T12:00:00.000Z
- Updated: 2026-09-14T18:13:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153619

FDA has published a request for comment on its research roadmap for a BsUFA 3 (Biosimilar User Fee Act) regulatory research pilot program. The [request for comment](https://downloads.regulations.gov/FDA-2023-N-0254-0001/attachment%5F1.pdf?ref=fdaweb.com) says the BsUFA 3 commitment letter between FDA and industry representatives that led to the reauthorization of the user fee program included a commitment for FDA to pilot a regulatory science research program to further enhance regulatory decision-making and facilitate science-based recommendations in areas foundational to biosimilar development.

The pilot program has two demonstration projects: **(1)** advancing the development of interchangeable products and **(2)** improving the efficiency of biosimilar product development.

The [Roadmap](https://downloads.regulations.gov/FDA-2023-N-0254-0001/attachment%5F2.pdf?ref=fdaweb.com) highlights scientific areas where advancement is expected to impact science-based recommendations and regulatory decision-making. FDA says it is seeking input from patients, researchers, non-profit organizations, companies, and other stakeholders on the research strategy and priorities and any additional regulatory science research gaps.