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Amgen: Biosimilars 'Notice' Not Conditioned On 'Patent Dance'

This article was originally published in Scrip

Executive Summary

The 180-day notice of commercial marketing for biosimilars is a "standalone" measure in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and there's nothing in the law or in a ruling last summer from an appeals court that "conditions" the provision on any other part of the statute, including a biosimilar maker's compliance with sharing its application with the branded firm, Amgen Inc. charged in new court documents in its lawsuit against Apotex Inc.

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