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Home » U.S. FDA Proposes Naming Convention for Biosimilars, Reference Products

U.S. FDA Proposes Naming Convention for Biosimilars, Reference Products

September 8, 2015
Pharmaceuticals Regulatory Affairs
The U.S. Food and Drug Administration released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix.

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