Back to: BsUFA III Regulatory Science Pilot Program: Progress Update
Presenter
Susan Winckler, RPh, Esq
Chief Executive Officer
Reagan-Udall Foundation for the FDA
Abstract
Susan Winckler from the Reagan Udall Foundation for the FDA, a nonprofit organization supporting the agency, presents insights gathered from a regulatory science accelerator focused on the FDA’s biosimilars program. This project involved convening five virtual conversations over three months with a diverse group of ten biosimilar development companies to explore and identify emerging areas and questions in regulatory science. The initiative specifically sought input from companies with varying levels of experience, including those not previously engaged with the BsUFA III Regulatory Science Pilot Program. During these dialogues, where the FDA served as a silent observer, developers discussed critical challenges such as the need for clarity on critical quality attributes and acceptable variability for analytical similarity, difficulties accessing reference product lots, complexities in pharmacokinetic studies including high patient dropout rates, the potential use of non-clinical in vitro immunogenicity assays as surrogates, and the application of modeling and simulation while acknowledging the need for caution against bias. The accelerator provided the FDA with valuable insights into developer challenges and allowed participants to share suggestions for agency programs. A comprehensive report detailing these learnings will be published later.