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Biosimilars Law Blog

Tag Archives: patent exchange

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

Posted in Biosimilar labeling, Biosimilars Patent Exchange, News & Events

Guide to Recent Biosimilar Activity by FDA and in the Supreme Court

The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the