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BioPharmaceutical United States Regulation

Biosimilar Interchangeability: Limited Exclusivity Should Mean Limited Testing – GPhA

This article was originally published in The Pink Sheet Daily

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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