Samsung Bioepis starts phase III trial for eculizumab copy biological

Biosimilars/News | Posted 23/08/2019 post-comment0 Post your comment

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Anaemia 2 V13J18

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.

Korea’s Ministry of Food and Drug Safety (MFDS) gave approval for Samsung Bioepis to start the phase III trial of its eculizumab copy biological (SB12) on 26 June 2019.

The study will compare the efficacy, safety, pharmacokinetics and immunogenicity of SB12 versus the originator drug, Soliris. Alexion’s Soliris was approved in Korea in 2010 and received an expanded indication for aHUS in 2016. The trial is a multinational, multicentre, double-blind, randomized, active-controlled, study. Samsung Bioepis plans to carry out the study in 50 patients with PNH.

Samsung Bioepis also intends to market SB12 in China. The company made a licensing agreement with C-Bridge Capital in February 2019 to develop and commercialize next-generation copy biologicals in China. The agreement covers multiple candidates, including SB12, SB3 (trastuzumab) and SB11 (ranibizumab) [1].

Editor’s comment
It should be noted that copy biologicals approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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1. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis makes deals for copy biologicals in China []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from:

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Source: Korea Biomedical Review

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