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28 February 2017Americas

Fed Circuit erred in Sandoz v Amgen, says solicitor general

The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration (FDA), according to the acting solicitor general.

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More on this story

Americas
12 June 2017   The US Supreme Court has ruled that biosimilar applicants may provide notice to the manufacturer before obtaining a licence from the Food and Drug Administration for their biosimilars.
Americas
22 February 2017   The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), has filed a brief in support of Sandoz’s petition for certiorari in the pending Sandoz v Amgen case.
Americas
16 January 2017   The US Supreme Court has agreed to hear the biosimilars dispute between Amgen and Sandoz.