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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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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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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Americas

Fed Circuit erred in Sandoz v Amgen, says solicitor general

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

Fed Circuit erred in Sandoz v Amgen, says solicitor general

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.