Progress Update on the BsUFA III Regulatory Science Pilot Program

07/15/2025

In January 2025, the US Food and Drug Administration (FDA) posted a progress update video about the third iteration of the Biosimilar User Fee Act (BsUFA III) regulatory science pilot program by sharing results from recent studies, outcomes of round table discussions, and upcoming milestones. The BsUFA program assesses and collects fees from biologics/biosimilar manufacturers in exchange for expediting the 351(k) biologics license application process. The regulatory science pilot program is a branch of BsUFA that uses a portion of the fees collected in order to fund research that focuses on accelerating and advancing the development of interchangeable products and improving the efficiency of biosimilar development. To meet these goals, the program has 6 “research priorities”:

1.   Characterize relationships between product quality attributes (physiochemical or biological) with clinical performance.

2.   Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributes.

3.   Define best practices for assessing and reporting product quality attributes.

4.   Develop alternatives to the comparative clinical immunogenicity assessment(s).

5.   Define approaches that will increase feasibility of biosimilar development (e.g., PD biomarkers, modeling and simulation).

6.   Identify user interface differences that will likely lead to difference in use error rates or use success rates in the context of pharmacy substitution.

Through these priorities, the project hopes to increase reliance of a demonstration of biosimilarity on analytical data as well as reduce the size of studies involving human participants. This would lowering the overall cost of biosimilar development which in turn lowers biosimilar prices on the market and puts less participants at risk in what may be considered redundant studies. Since the program began in 2015 until 2024, 63 biosimilars from 17 reference products have been approved and $36 billion have been saved as a result.

The third iteration of this program began in October 2022 and, as outlined in their commitment letter, is set to have a public meeting/interim report later this year on October 30, 2025 to give an update on the project. The project aims to be completed by September 30, 2027 after which a strategy document will be developed that will summarize all of the project’s efforts and suggest ways the biosimilar development process can be optimized industrywide. The full webinar as well as the slides and links used are available on the FDA website and contains progress updates from multiple individuals working on the project as well as a Q&A session at the end to provide a comprehensive overview of what the regulatory science pilot program entails.

-The Clinical Pathways Team

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