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Supreme Court to Review Biosimilar Battle Between Amgen and Sandoz

(STAT Plus/Pharmalot) Apr 25, 2017 - A hotly anticipated hearing takes place at the US Supreme Court on Wednesday about biosimilars and the eventual decision is expected to have widespread implications for health care costs.

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Howard S. Hochster, MD (Posted: April 26, 2017)

quotesFascinating legal wrangling as the Supremes parse the wording of the BPCIA (Biologic Price Competition and Innovation Act). At stake, whether the biosimilar manufacturer must supply the originator company with a copy of their BLA application, and whether an additional 180 day waiting period Is required following actual FDA approval of the biosimilar for the originator to issue patent litigation. This would invalidate notification prior to the formal licensure. Who knew biosimilars could be so exciting and reach SCOTUS ??quotes

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