Revised Biosimilar Research Roadmap Out

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 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.