Biosimilar Interchangeability: Limited Exclusivity Should Mean Limited Testing – GPhA

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.

The Biologics Price Competition and Innovation Act's limited exclusivity award for a first-time interchangeable product argues against requiring biosimilar sponsors to demonstrate interchangeability for every indication on a reference product's label, the Generic Pharmaceutical Association and its Biosimilars Council said.

The one-year exclusivity period provided in the BPCIA would be insufficient to incentivize a biosimilar sponsor to undertake such extensive clinical research as requested by

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