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FDA Updates on Biosimilar Development and Postapproval Manufacturing Changes
The US Food and Drug Administration (FDA) has published two important guidance documents addressing the development, approval and lifecycle management of biosimilar and interchangeable biosimilar products. The Questions and Answers on Biosimilar Development and the BPCI Act, Revision 4, and Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers were issued in October 2026. Together, these guidance documents provide reco
Sharan Murugan
Oct 115 min read
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...
Sharan Murugan
Jul 22, 20242 min read