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# Revised Biosimilar Research Roadmap Out
- URL: https://www.fdaweb.com/revised-biosimilar-research-roadmap-out/
- Published: 2024-01-31T12:00:00.000Z
- Updated: 2026-09-14T14:21:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156254

FDA has released a Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap that provides updated information about the biosimilar regulatory science research pilot program’s research priorities. The [revised roadmap](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTc1Nzk5L2Rvd25sb2FkP2F0dGFjaG1lbnQ9JnV0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyNDAxMzEuODk0Mjk4NTEifQ.XsFBQCCliHxrRR9zlJnqdSKvG8BSkKc7u9Yv-CWvCQ4/s/1255931999/br/236284797221-l?ref=fdaweb.com) says the draft that was issued in 1/2023 was updated from public docket comments and a 10/2023 public meeting. FDA says the revision remains consistent with the overall goals and demonstration projects outlined in the BsUFA 3 agreement. It is said to also provide additional clarity and context on the selection of research guidelines and how advancing those priority areas is expected to affect science-based recommendations and regulatory decision-making at FDA.

The agency says researchers both external and internal to FDA should use the roadmap to guide research proposals, collaborations, and other efforts to seek BsUFA 3 research funding opportunities.