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Sandoz Dares SCOTUS To Unravel Biosimilars Law's Riddles

This article was originally published in Scrip

Executive Summary

The US Court of Appeals for the Federal Circuit read too much into the word "licensed" in a provision of the Biologics Price Competition and Innovation Act (BPCIA) when the majority of a three-judge panel this past July reached its "erroneous" conclusion that biosimilars makers must give innovators 180 days notice of commercial marketing after the FDA has given its nod for the copycat to enter the US market, Sandoz Inc. argued in a petition to the US Supreme Court.




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