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Apotex: Amgen's Biosimilar Injunction An 'Abuse Of Discretion'

This article was originally published in Scrip

Executive Summary

A Florida district judge's decision to grant a preliminary injunction (PI) to Amgen Inc. against Apotex Inc. preventing it from marketing its biosimilar of Neulasta (pegfilgrastim) was an "abuse of discretion" and amounts to a de facto 180-day extension of the 12-year exclusivity protection for innovator drugs provided by the Biologics Price Competition and Innovation Act (BPCIA), the latter company said in newly filed court documents.

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