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Amgen Labeling

Kilpatrick

The Supreme Court Leaves Skinny Labels to Another Day

Kilpatrick on

The Supreme Court recently rendered two important decisions for the biopharma industry. In the first decision, the Supreme Court ruled on enablement of genus claims for therapeutic antibodies, unanimously affirming the...more

Faegre Drinker Biddle & Reath LLP

FDA's Draft Guidance to Help Manufacturers in Labeling Biosimilars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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