Back to: BsUFA III Regulatory Science Pilot Program: Progress Update
Presenters
Kimberly Maxfield, PhD
Pharmacologist
BsUFA Reg Sci Lead
Office of Therapeutic Biologics and Biosimilars (OTBB)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
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
This presentation segment features Kimberly Maxfield and Darlese Solorzano discussing future plans for the BsUFA Regulatory Science Pilot Program, specifically focusing on the interim public meeting scheduled for September 18, 2025. This meeting, a major deliverable outlined in the BsUFA III commitment letter, will be held at the FDA White Oak campus and offer a virtual option. Key focus areas for the meeting include lessons learned from establishing the program, research project report outs, and the role of regulatory science in biosimilar development. Given time constraints, only a selection of the 19 total research projects will receive oral presentations. To gather input for planning, Darlese Solorzano conducts live polling during the webinar, asking the audience which research projects under research priorities A, B, C, D, and E they are most interested in hearing about at the interim meeting. Audience feedback from this real-time poll helps inform the meeting’s agenda.