BsUFA III Regulatory Science Pilot Program: Research Roadmap

The US Food and Drug Administration (FDA) yesterday released the  Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap to provide updated information about the biosimilar regulatory science research pilot program research priorities.

The draft roadmap was first released January 2023 and this revision was informed by  public docket comments and a  2-part public meeting held in October 2023. The revised research roadmap remains consistent with the overall goals and demonstration projects outlined in the BsUFA III commit0vment letter. It also provides additional clarity and context on the selection of research priorities and how advancing these priority areas is expected to impact science-based recommendations and regulatory decision making at the FDA.

To this end, the FDA focused the research priorities on the composition of the data package, and ways to streamline it, to support approval of a biosimilar or interchangeable biosimilar product while still ensuring that the submission can support the requirements for approval. Revised research priorities are focused into two areas where the data package to support approval of a biosimilar or interchangeable biosimilar product: