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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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Americas
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
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
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
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
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
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.