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12 June 2017Americas

SCOTUS allows early notice from biosimilar applicants

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 (FDA) for their biosimilars.

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More on this story

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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More on this story

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.
Americas
BIO 2017: Panellists talk Amgen Sandoz biosimilar battle
23 June 2017   Earlier this month, the US Supreme Court handed down its decision in the biosimilars battle between Amgen and Sandoz, centring on the Biologics Price Competition and Innovation Act.
Americas
State law can’t compel ‘patent dance’, rules Federal Circuit
15 December 2017   State law cannot force drug makers to participate in the ‘patent dance’ provided for by the Biologics Price Competition and Innovation Act.

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