FDA's Playbook for Biosimilar Meet-and-Greets
Published Date: 7/21/2025
Notice
Summary
The FDA just released final advice on how they’ll hold official meetings with companies making biosimilar drugs—those are copies of biologic medicines. This helps drug makers know what to expect when working with the FDA, speeding up the review process. If you’re in the biosimilar business, get ready for clearer, smoother talks starting now, with no extra fees involved.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Final FDA Guidance on Biosimilar Meetings
If you develop biosimilar or interchangeable biologic drugs, the FDA issued final guidance describing how formal meetings between sponsors/applicants and the agency will be handled. The guidance covers products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and finalizes the draft issued on August 11, 2023.
No Extra Fees for Formal Meetings
The guidance indicates that sponsors or applicants of biosimilar products will not face extra fees for these formal meetings with the FDA. That means biosimilar developers should not expect new meeting-related charges under this guidance.
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