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Amgen, Sandoz Seek Rehearing On Biosimilar Court Case

This article was originally published in SRA

Executive Summary

Amgen and Sandoz have both filed petitions asking the US Court of Appeals for the Federal Circuit to rehear a panel ruling interpreting the provisions of the biosimilars statute. Amgen argues against the finding that the information exchange process in the law is optional, while Sandoz objects to the panel’s decision that biosimilar sponsors must wait until Food and Drug Administration approval to provide notice of commercial launch1,2.




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