Zarxio Rehearing Denied; Biosimilars Questions Await Next Case
This article was originally published in Scrip
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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