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16 January 2017Americas

SCOTUS agrees to hear Amgen v Sandoz dispute

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

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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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Fed Circuit erred in Sandoz v Amgen, says solicitor general
28 February 2017   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, according to the acting solicitor general.


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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
Fed Circuit erred in Sandoz v Amgen, says solicitor general
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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
Fed Circuit erred in Sandoz v Amgen, says solicitor general
28 February 2017   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, according to the acting solicitor general.

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