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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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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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

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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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.

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

Fed Circuit erred in Sandoz v Amgen, says solicitor general

More on this story

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.

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

Fed Circuit erred in Sandoz v Amgen, says solicitor general