The District Court for Southern Florida ruled on 6 September 2016 that the manufacturing process for Apotex’s proposed filgrastim and pegfilgrastim biosimilars did not infringe Amgen’s ’138 patent. Judge Cohn, however, did not agree with Apotex’s counterclaim that the claims of the ’138 patent were invalid due to lack of enablement. Amgen’s US Patent No. 8,952,138 expires on 29 July 2031.

Apobiologix also indicated that the company recently filed a Petition for Certiorari with the US Supreme Court. The new petition challenges the Federal Circuit Court of Appeal’s ruling that the company may not launch its products until after providing 180-days’ notice following regulatory approval by the US Food and Drug Administration (FDA).

Apobiologix’s President, Steve Lydeamore, said that this victory ‘underscores the urgent need for the Supreme Court to rule that biosimilar applicants can provide their notice of intent to market prior to securing FDA approval for their products, as intended by the BPCIA [Biologics Price Competition and Innovation Act of 2009]’.

In its petition to the Supreme Court, Apotex has stated that ‘In this instance, the Circuit’s bar will operate only to keep a non-infringing, cost-saving FDA-approved biosimilar product out of the hands of consumers for an additional six months.’

This is the second petition filed during 2016 asking the Supreme Court to address the question. The Supreme Court has asked the US Solicitor General to give an opinion on the issue.

Apotex’s pegfilgrastim and filgrastim biosimilars were accepted for FDA review in December 2014 [1] and February 2015 [2], respectively. Apotex’s filgrastim biosimilar, Grastofil, was approved for marketing in the European Union (EU) back in October 2013 [3]. There are currently no pegfilgrastim biosimilars approved in the EU, however, the European Medicines Agency is currently reviewing four pegfilgrastim products [4].

Related article
Biosimilars in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
2. GaBI Online - Generics and Biosimilars Initiative. Second Apotex biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Second-Apotex-biosimilar-under-FDA-review
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – August 2016 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-August-2016

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