Healthcare act passes US Supreme Court constitutionality test giving birth to a defined biosimilar pathway


With a tip of the hat to PatentDocs, we are reminded that by allowing the Patient Protection and Affordable Care Act (PPACA) to stand, the U.S. Supreme Court has also allowed to stand congressional authority for the FDA to approve biosimilars (officially approved versions of pharmaceuticals produced by a different sponsor), comparable to the original drug and presumably allowing for lower prices for consumers.

USFDA (Food and Drug Administration) previously held that it needed new legislation to enable them to approve biosimilars, so the rest of the world has a head start on the U.S. FDA now has their authority, which is good news for biosimilar manufacturers, and important news to evaluators of the prospects for profitable new income streams.

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