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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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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.
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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 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.


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More on this story

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.
Americas
Biosimilars Council urges SCOTUS to limit biologics exclusivity period
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
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.

More on this story

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.
Americas
Biosimilars Council urges SCOTUS to limit biologics exclusivity period
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
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.

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