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Amgen sues Sandoz over etanercept biosimilar Posted 11/03/2016

Following the submission of application for approval of its etanercept biosimilar in the US, Sandoz is coming under fire from originator company Amgen.

US-based Amgen has filed a suit in the District Court of New Jersey on 26 February 2016 claiming that Sandoz infringed some of its patents for its arthritis blockbuster Enbrel (etanercept) by seeking US Food and Drug Administration (FDA) approval for its biosimilar.

Sandoz, the generics division of Novartis, announced on 2 October 2015 that FDA had accepted its application for its etanercept biosimilar (GP2015) [1]. This was followed by the news on 8 December 2015 that the European Medicines Agency (EMA) had also accepted the company’s regulatory submission for its proposed etanercept biosimilar (GP2015) [2].

In its patent infringement suit Amgen claims that in developing its biosimilar Sandoz is ‘piggybacking on the fruits of Immunex/AML and Roche’s trailblazing efforts’. Immunex originally developed Enbrel and was later acquired by Amgen, while Roche licenses the patent to Amgen.

Amgen also accuses Sandoz of using ‘clinical data generated by Immunex/AML’s investments’ by seeking approval for all indications included in the label of the reference product. Amgen says that the defendants only conducted clinical trials in psoriasis patients and ‘did not conduct any clinical trials on indications for which Enbrel had not already been demonstrated to be safe and effective’.

Amgen/Pfizer’s arthritis blockbuster Enbrel had sales of US$8.3 billion in 2014. The patents on Enbrel only expire in the US in November 2028, after Amgen was granted a new patent [3]. In Europe, the patents already expired in August 2015 [4].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
2.   GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
3.   GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
4.   GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries

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Source: US District Court of New Jersey

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