Etanercept inhibits the inflammatory molecule tumour necrosis factor (TNF), diminishing the inflammatory response in a range of auto-immune conditions. It can be used to treat various forms of arthritis and has been sold by Amgen since 1998, with the trade name Enbrel. Enbrel generated almost US$5 billion for Amgen in 2018 and patents on the drug do not expire until 2029.

Sandoz, a division of Novartis, has developed a competitor to Enbrel. Their biosimilar version of etanercept is called Erelzi (etanercept-szzs) and has been approved by the US Food and Drug Administration (FDA) since 2016 [1]. Phase III trials have shown positive results for Erelzi [2], but Sandoz has so far been unable to launch the product on the US market due to patent infringement disputes.

The issue was taken to court and in early August 2019, the US District Court for New Jersey ruled that two Amgen patents covering Enbrel and methods of producing it are valid. There were seven patient infringement claims against Sandoz, with the Court ruling that the company had not met its burden to prove all seven claims to be invalid.

Chairman and CEO of Amgen Robert A Bradway said he was pleased with the decision. ‘Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients.’

Shortly after, Sandoz announced plans to appeal the ruling to the US Court of Appeals for the Federal Circuit. Both parties have agreed to an expedited appeal.

President of Sandoz US, Carol Lynch, said Sandoz ‘respectfully disagrees’ with the Court’s ruling. ‘Valid intellectual property should be respected; however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible.’

Sandoz, the first company to launch a biosimilar in the US, say the ruling prevents the launch of affordable treatment options for US patients with chronic inflammatory diseases. They say they are committed to increasing patient access to biosimilars and contributing to a more sustainable healthcare system.

The company will be keen to launch the product as soon as possible, as FDA continues to approve alternative etanercept biosimilars, most recently from Korean biosimilars maker Samsung Bioepis [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi
2. GaBI Online - Generics and Biosimilars Initiative. Positive results for adalimumab and etanercept biosimilars from Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-adalimumab-and-etanercept-biosimilars-from-Sandoz
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves etanercept biosimilar Eticovo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-etanercept-biosimilar-Eticovo

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