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Zarxio Rehearing Denied; Biosimilars Questions Await Next Case

This article was originally published in Scrip

Executive Summary

The US Court of Appeals for the Federal Circuit on Oct. 16 said it won't rehear arguments in a lawsuit brought by Amgen Inc. against Sandoz Inc. involving its biosimilar Zarxio (filgrastim-sndz), leaving several lingering questions about the Biologics Price Competition and Innovation Act (BPCIA) – the law that created the regulatory pathway for the FDA to approve biosimilars – waiting for another case.


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