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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