FDA Releases Research Roadmap for Biosimilars Pilot Program

FDA released the Biosimilar User Fee Amendments (BsUFA) III Regulatory Science Pilot Program: Research Roadmap to provide additional information about the biosimilar regulatory science research pilot program. The agency also opened a public docket to collect feedback, according to a press release.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions. FDA will pilot a regulatory science program to facilitate biosimilar and interchangeable biological product development, as outlined in the BsUFA reauthorization commitment letter for fiscal years 2023–2027.

The regulatory research pilot program is targeted at knowledge gaps and direct research to advance biosimilar development. The BsUFA III regulatory research pilot program has two goals, also known as demonstration projects, which are: advancing the development of interchangeable products, and improving the efficiency of biosimilar product development.

In the roadmap, research areas are highlighted where advancement is expected to impact science-based recommendations and regulatory decision making. More specifically, the research aims to:

• increase the accuracy and capability of analytical (structural and functional), and chemistry, manufacturing, and controls characterizations
• develop alternatives to and/or reducing the size of studies involving human subjects.

The research team, both external and internal to FDA, should use this roadmap to guide research proposals, collaborations, and other efforts as they seek BsUFA III research funding opportunities. Further, the roadmap includes information on research project deliverable dates and methods to consider for research conducted as part of the pilot program.

In all, the objective of the pilot program is to increase the efficiency and predictability of biosimilar development to help reduce the cost and time of development. This helps increase availability and access to much needed biological treatment options for patients.

Source: FDA