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Court Probes Rationale Of Biosimilars' 180-Day Notice

This article was originally published in Scrip

Executive Summary

There was a lot of inside baseball being played at the US Court of Appeals for the Federal Circuit during April 4 oral arguments when Amgen Inc. battled Apotex Inc. over whether Congress intended for it to be mandatory for biosimilar makers to provide 180 days notice of commercial marketing (NCM) to the reference product sponsor (RPS) after the FDA licenses a copycat product.


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