FDA Finalizes Guidance On Naming Biologics and Biosimilars


The FDA has finalized guidance on naming biosimilars and biologics, and has made a departure from WHO and European rules. The FDA’s rules on four-letter FDA-designated meaningless suffixes will allow companies to submit 10 suffixes to the FDA for consideration. Medical professionals had called on the FDA to use meaningful suffixes which could have made the drugs easier to distinguish.

Read the source article at RAPS.org

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