Biosimilar Interchangeability: Limited Exclusivity Should Mean Limited Testing – GPhA

This article was originally published in The Pink Sheet Daily

15 Apr 2016
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

Although AbbVie is petitioning FDA for expansive definition of 'any given patient' requirement, GPhA and its Biosimilars Council argue that Congress knew how to write the statute more broadly, but didn't.

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Biosimilar Interchangeability: Limited Exclusivity Should Mean Limited Testing – GPhA

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