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What's in a Name? A Four-Letter Suffix to Be FDA Compliant

The BPCIA and the Debate Over Naming Biosimilars - Most drugs on the market today are small-molecule compounds with active pharmaceutical ingredients that can be duplicated to create “generic” drugs. It is impossible,...more

FDA's Draft Guidance to Help Manufacturers in Labeling Biosimilars

The passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 paved the way for the introduction of biosimilars in the United States. Biosimilars are large-molecule drugs that are highly similar, but not...more

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