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Hospira: Amgen's Biosimilar Lawsuit Fatally Flawed

This article was originally published in Scrip

Executive Summary

Amgen Inc.'s lawsuit claiming Hospira Inc. violated certain provisions of the Biologics Price Competition and Innovation Act (BPCIA) – the law that established the regulatory pathway for the FDA to approve biosimilars – is fatally flawed because it's seeking to "privately enforce" statutory provisions, despite the fact the US Congress did not create a structure for such enforcement, the latter company charged in court documents filed this week.


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