Hospira: Amgen's Biosimilar Lawsuit Fatally Flawed
This article was originally published in Scrip
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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