Back to: BsUFA III Regulatory Science Pilot Program: Progress Update
Presenter
Darlese Solorzano, MS, MBA
Senior Program Manager
BsUFA III Regulatory Science Pilot Program
Office of Biotechnology Products (OBP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Darlese Solorzano, Senior Program Manager for the BsUFA III Regulatory Science Pilot Program, is providing an overview of the program during the webinar. She starts by presenting the current state of biosimilars at the FDA, detailing the number of approvals, interchangeable products, and marketed products, and highlighting the significant cost savings and increased patient access achieved. Solorzano explains that the pilot program stems from the BsUFA III commitment letter, designed to enhance regulatory decision making and facilitate science-based recommendations for biosimilar development. The program focuses on two key areas: improving the efficiency of biosimilar product development and advancing the development of interchangeable products. To achieve these goals, the program focuses on the composition of the 351(k) BLA package, aiming to increase the reliance on analytical data and leverage alternatives to and/or reduce the size of studies involving human subjects. She outlines the research priorities that support these aims, discusses the program’s required deliverables including upcoming public meetings and reports, and describes various stakeholder engagement efforts such as public feedback dockets and virtual roundtables with developers.