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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SCOTUS allows early notice from biosimilar applicants

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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.

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SCOTUS agrees to hear Amgen v Sandoz dispute

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Americas

SCOTUS allows early notice from biosimilar applicants

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

SCOTUS agrees to hear Amgen v Sandoz dispute

16 January 2017 The US Supreme Court has agreed to hear the biosimilars dispute between Amgen and Sandoz.

More on this story

Americas

SCOTUS allows early notice from biosimilar applicants

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

SCOTUS agrees to hear Amgen v Sandoz dispute

16 January 2017 The US Supreme Court has agreed to hear the biosimilars dispute between Amgen and Sandoz.