Positive phase III results for Samsung Bioepis’ Soliris biosimilar

Biosimilars/Research | Posted 08/07/2022 post-comment0 Post your comment

Samsung Bioepis announced that its biosimilar to Soliris (eculizumab) has comparable efficacy and safety and is bioequivalent to the originator. 

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The results of the phase III clinical trial for Samsung Bioepis’ biosimilar were announced in June 2022 at the annual conference of the European Society of Hematology (EHA). The trial of the biosimilar, also known as SB12, began in 2019 and was completed in October 2021, it was carried out in eight countries, including South Korea [1]. Samsung Bioepis’ eculizumab is a biosimilar of the highly priced, Soliris, developed by US pharmaceutical company, Alexion. Soliris was approved in the United States by the Food and Drug Administration (FDA) in 2007 and posted US$1.87 billion in global sales in 2021.

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 [2].

Samsung Bioepis hopes to file for approval in the US in the coming months. It will be in competition with Amgen for first approval of a biosimilar of eculizumab [3], although Amgen has a deal with Alexion not to launch the biosimilar until 2025 [4].

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1. GaBI Online - Generics and Biosimilars Initiative. Advances for Samsung Bioepis eculizumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/research/advances-for-samsung-bioepis-eculizumab-and-trastuzumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-eculizumab
3. GaBI Online - Generics and Biosimilars Initiative. Amgen predicts a steady flow of biosimilar launches [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/general/amgen-predicts-a-steady-flow-of-biosimilar-launches
4. GaBI Online - Generics and Biosimilars Initiative. Alexion delays Soliris biosimilar until 2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/policies-legislation/Alexion-delays-Soliris-biosimilar-until-2025

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