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US court dances with biosimilar law's complexity in Zarxio fight

This article was originally published in SRA

Executive Summary

While the case before the US Court of Appeals for the Federal Circuit on 3 June was a dispute between Amgen and Novartis' Sandoz unit over how soon the latter firm should be able to market its biosimilar medicine Zarxio (filgrastim-sndz), it was the knotty intricacies of the Biologics Price Competition and Innovation Act (BPCIA) – the law that created the regulatory pathway for the Food and Drug Administration to approve biosimilars – that was on trial.




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