Etanercept biosimilars delayed until 2029 in US

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Etanercept biosimilars delayed until 2029 in US

Biosimilares/Novedades | Posted 14/01/2022 0 Post your comment

Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.

South Korean-based Samsung Bioepis (Samsung and Biogen’s joint venture) will be unable to sell its etanercept biosimilar Eticovo (etanercept-ykro) in the US until 2029. This news comes despite the fact that Eticovo received approval from the US Food and Drug Administration (FDA) back in April 2019 [1].

Although the original patent on Enbrel was due to expire in 2012, Amgen was granted a second patent, which extended exclusivity until 2029. There are therefore no biosimilars available in the US, despite three being available in the EU [2]. Without competition from biosimilars, the cost of Enbrel in the US has increased since its launch, and was estimated at US$4,944.95 per month in 2019.

Samsung Bioepis tried to invalidate this second patent in a lawsuit. However, the District Court of New Jersey ruled on 3 November 2021 in favour of Amgen, Immunex, and Roche in the Enbrel patent infringement lawsuit.

According to the ruling, Samsung Bioepis is permanently enjoined from ‘making, using, offering to sell, or selling within the United States, or importing into the United States any product containing etanercept’. In addition, the company ‘shall immediately destroy any remaining Bioepis etanercept product that has been imported into the United States’. The permanent injunction will only terminate upon the expiration of both the ’182 Patent and ’522 Patent on 24 April 2029.

This is the second Enbrel patent challenge to be denied in the US. In May 2021, it was announced that the US Supreme Court denied a petition by pharmaceutical company, Sandoz, to review the decision concerning its etanercept biosimilar, Erelzi (etanercept-szzs) [3]. Sandoz’s more affordable Erelzi, was also approved by FDA for use in the US back in 2016 [1]. However, like Eticovo, will not be available in the US to treat patients with autoimmune and inflammatory diseases until 2029.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves etanercept biosimilar Eticovo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-etanercept-biosimilar-Eticovo
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
3. GaBI Online - Generics and Biosimilars Initiative. US Supreme Court rejects Enbrel patent challenge from Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/general/us-supreme-court-rejects-enbrel-patent-challenge-from-sandoz

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Source: JDSUPRA, Korea Biomedical Review