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Completion of clinical trials for SB 12 a eculizumab biosimilar.

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Published:29th Nov 2021
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.

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 ( now owned by AstraZeneca). 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.

Condition: Paroxysmal Nocturnal Haemoglobinuria
Type: drug

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