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Biosimilars Law Blog

Tag Archives: state law

Posted in Biosimilars Patent Exchange, News & Events

Supreme Court Issues Landmark Biosimilar Ruling

On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and is expected to significantly impact the approval and patent litigation processes for biosimilar applications. First, the BPCIA requires a biosimilar applicant