Upcoming FDA Public Meeting: BsUFA III Regulatory Science Program – Interim Review
🗓 Date: September 18, 2025
🕘 Time: 9:00 AM – 3:00 PM ET
📍 Hybrid Format: Attend in person or virtually
🔗 Register: Eventbrite Link
🔗 More Info: FDA Event Page
Under the Biosimilar User Fee Act (BsUFA III), the FDA committed to advancing regulatory science that supports biosimilar development and interchangeability.
This interim public meeting will:
✅ Review pilot program progress
✅ Highlight research from FDA awardees
✅ Feature insights from FDA staff and biosimilar industry experts
✅ Invite stakeholder input on future priorities
🎯 Focus Areas:
• Development of interchangeable biosimilars
• Improving efficiency in biosimilar product development
Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA committed to piloting a regulatory science program that focuses on: 1) advancing the development of interchangeable products; and 2) improving the efficiency of biosimilar product development. For stakeholder engagement, this commitment includes publishing an interim progress report and holding an interim public meeting approximately midway through the pilot program.
The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.
The meeting agenda includes an overview of the regulatory science program, presentations by internal and external awardees conducting research projects under the BsUFA III regulatory science program, and panel discussions by FDA staff and representatives from the biosimilar industry.
The Federal Register Notice, additional materials, and any other updates will also be posted to this website as they become available.
🔍 A great opportunity for professionals in biotech, regulatory affairs, biosimilars, and life sciences to stay informed and engage with the FDA.
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