Advances for Samsung Bioepis’ eculizumab and trastuzumab biosimilars

Biosimilars/Research | Posted 26/11/2021 post-comment0 Post your comment

Samsung Bioepis has announced the completion of its global phase III clinical trials of a biosimilar of Soliris (eculizumab), for treating certain rare blood diseases. In addition, it also presented its results from a five-year follow-up study that showed its biosimilar Ontruzant (trastuzumab) has comparable cardiac safety profiles and long-term efficacy as the originator, Herceptin.

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Samsung Bioepis’ phase III trial of its eculizumab biosimilar began in 2019 and was completed in October 2021. The trial was carried out in eight countries, including South Korea. Its eculizumab product is a biosimilar of the highly priced, Soliris, developed by US pharmaceutical company, Alexion. Eculizumab is used to treat rare blood diseases paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Samsung hopes that this product can soon be added to its portfolio of approved biosimilars and helps improve patients access to expensive biological medicines.

At the European Society for Medical Oncology (ESMO) Virtual Congress 2021, in September 2021, Samsung Bioepis presented the longest monitoring data of patients treated with a trastuzumab biosimilar versus the originator, Herceptin, for human epidermal growth factor receptor 2 positive (HER2+) early or locally advanced breast cancer. They were able to show comparable cardiac safety profile and long-term efficacy between biosimilar Ontruzant and the originator, Herceptin. Ontruzant has been approved in several jurisdictions, including Australia, Brazil, Europe, South Korea and the US [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 26). Available from:

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