US Supreme Court to review 180-day notice for biosimilars

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The US Supreme Court announced on 13 January 2017 that it has agreed to hear a case centred on whether biosimilar makers have to give 180 days of notification to the originator biological manufacturer before launching their biosimilar.

The case has been brought to the Supreme Court by Sandoz (the generics division of Novartis) after a lower court ruling that found that biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market.

The announcement has come as a surprise after the Supreme Court’s decision in December 2016 that it would not hear a similar case involving Apotex vs Amgen. Although in that case, Apotex agreed to litigate all the patents proposed by Amgen, and argued that it is not required to provide pre-marketing notice, since there are no other patents that Amgen could assert.

In the Amgen vs Sandoz case, Amgen originally sued Sandoz for violating the Biologics Price Competition and Innovation Act (BPCI Act) by providing notice before its product was licensed [1]. Sandoz appealed to the Supreme Court in February 2016 after the US Court of Appeals for the Federal Circuit concluded that the 180-day notification is required, unless a biosimilar producer discloses their intent to launch the product and resolves patent disputes ahead of the approval.

Sandoz claims in its petition that not only did it provide Amgen with more than 180 days’ notice of its intent to market Zarxio (filgrastim-sndz), giving Amgen time to bring suit (which it did) and seek a patent-based injunction (which it did not), but Amgen’s exclusivity period for Neupogen had expired, as Amgen ‘already had enjoyed 24 years of exclusivity.’

Although the high court’s decision will have no effect on the original case as Sandoz launched Zarxio in September 2015 after waiting 180 days, it could set a precedent on how the information exchange processes under the BPCI Act should be interpreted. This in turn could have major implications for how soon biosimilars can reach the market in the US.

Related article
Amgen sues Sandoz over etanercept biosimilar

1.    GaBI Online - Generics and Biosimilars Initiative. Amgen sues Sandoz over filgrastim biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from:

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Source: Big Molecule Watch, Patently-O, PharmaPatents, RAPS

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