Search Results: Naming

FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.”  The guidance provides that naming for originator biological products, related biological products, and biosimilars should include a “core name” followed by a four-letter suffix.  The core name typically will be the USAN Council name for the Reference Product (RP)….

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