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Home » Amgen Asks if Drug Suffixes for Biologics and Biosimilars Could Lead to Misbranding Charges
Amgen Asks if Drug Suffixes for Biologics and Biosimilars Could Lead to Misbranding Charges
In comments on the FDA’s draft guidance on drug and biologics labeling, Amgen urged the agency to follow a precedent set by a previous agency opinion that a USP monograph title consisting of a core name without a suffix does not apply to biologics whose nonproprietary names include a suffix.