Thank you for posting this Mark. I am curious to learn FDA current thinking on this topic. My understanding is that the biggest challenge is that the product is the process, not a chemically defined product. So proving comparability when you don't have access to the process is challenging. Even sponsors with full access to both processes have challenges to show analytical and clinical comparability sometimes.
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Joleen White Ph.D.
AAPS 2024 Global Health Community Chair
Bioanalytical 101 Course Development
Senior Advisor
BioData Solutions LLC
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 07-11-2025 10:23
From: Mark Arnold
Subject: FDA TO HOLD A PUBLIC WORKSHOP ON THE DEVELOPMENT OF INTERCHANGEABLE BIOSIMILAR PRODUCTS
The following is directly from an FDA e-mail and may be of interest to those working with Biosimilars:
Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA will hold a scientific workshop on the development of interchangeable products to help identify future needs (e.g., guidance, research) on or before October 31, 2025. This meeting fulfills the BsUFA III commitment. The meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry. For more information about the meeting and registration, visit the meeting website. |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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