EMA recommends approval of eculizumab biosimilar Epysqli

Biosimilars/News | Posted 30/05/2023 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 March 2023 that it had adopted a positive opinion for Epysqli.

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Epysqli, also knowns as SB12, is a biosimilar candidate developed by Samsung Bioepis referencing Alexion’s biological product Soliris (eculizumab).

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy [1].

Epysqli has been recommended for approval for the treatment of adult and children patients with PNH. This news comes less than a year after the company announced the results of the phase III clinical trial for SB12 at the annual conference of the European Society of Hematology (EHA) [2]. 

If EC marketing authorization is granted, Epysqli would become Samsung Bioepis’ first haematology biosimilar, further expanding the company’s biosimilars portfolio.

Samsung Bioepis’ eculizumab biosimilar joins Amgen’s Bekmev that announced it had received a recommendation for the granting of marketing authorization by EMA’s CHMP in February 2023 [3].

In the US, a patent settlement between Amgen and Alexion was reached on 28 May 2020 that prevented the release of Amgen’s biosimilar Soliris until 1 March 2025 [4]. 

Soliris was first approved in the US in 2007 and posted US$1.87 billion in global sales in 2021 [1]. The patents for Soliris expired in the US on 16 March 2021 and in Europe on 1 May 2020 [5]. 

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 30]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Samsung Bioepis’ Soliris biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 30]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-samsung-bioepis-soliris-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of eculizumab biosimilar Bekemv [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 30]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-eculizumab-biosimilar-bekemv
4. GaBI Online - Generics and Biosimilars Initiative. Alexion delays Soliris biosimilar until 2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 30]. Available from: www.gabionline.net/policies-legislation/Alexion-delays-Soliris-biosimilar-until-2025
5. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003

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