Gary Blakeley /
22 June 2016Americas

SCOTUS asks Obama for views on Amgen v Sandoz dispute

The US Supreme Court has invited the solicitor general to file briefs in the Amgen v Sandoz biosimilars case in order to obtain the Obama administration’s view on the dispute between the two companies.

Sandoz and Amgen have petitioned the court to review the case, which was decided back in July 2015 by the US Court of Appeals for the Federal Circuit.

The court’s request for the solicitor general to file briefs is the latest development in the high profile dispute. The subject of the dispute was Sandoz’s  cancer drug Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen, which launched on September 3 last year.

Zarxio was the first biosimilar product to be licensed under the Biologics Price Competition and Innovation Act (BPCIA), which provides a shortened regulatory pathway for biosimilar drugs.

The Federal Circuit said in a ruling handed down in July last year that the patent dance exchange is optional under provisions set out in the BPCIA.

The court, however, added that a biosimilar applicant must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration.

Amgen appealed against the part of the ruling which stated that the patent dance was optional, while Sandoz appealed against the 180-days aspect.

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