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Samsung Bioepis Announces Post-Hoc Analysis of Phase 3 Results for Eculizumab Biosimilar

May 30, 2024

On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16 June 2024. 

The analysis compared the proportion of patients with paroxysmal nocturnal hemoglobinuria (PNH) who remained transfusion-free when treated with SB12 or Soliris®.  Samsung Bioepis reports that the data “adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients”.   

Epysqli® (SB12) was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024.   

Epysqli® is one of two eculizumab biosimilars approved in Europe, including Amgen’s Bekemv®, which was EMA approved in April 2023. 

Alexion filed proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking provisional measures in relation to EP 3 167 888 (method of treating PNH).  In January 2024, Alexion also commenced US BPCIA litigation against Samsung Bioepis alleging infringement of 6 US eculizumab patents.