Samsung Bioepis gets approval to sell biosimilar in Europe
Dae-Kyu Ahn
May 31, 2023 (Gmt+09:00)
South Korea's Samsung Bioepis has received approval in Europe to sell a biosimilar of Soliris, a drug for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH).
The company on Tuesday said it obtained approval from the European Commission for EPYSQLI™(Eculizumab).
Developed by the Boston-based Alexion Pharmaceuticals, Soliris is a treatment for intractable rare diseases such as paroxysmal nocturnal hemoglobinuria but its annual cost is well out of reach for most people at 400 million ($303,431) to 500 million won.
Samsung Bioepis now has seven biosimilars on the European market including EPYSQLI.
Industry observers say Samsung Bioepis has secured the first pipeline in the blood sector by breaking through the biosimilar niche market, which is marked by high development difficulty.
"EPYSQLI demonstrated equivalence through comparative clinical trials with the original drug to improve patient accessibility to ultra-expensive medicine," said Jang Jun-ho, a professor at the Department of Hematology and Oncology of Samsung Medical Center in Seoul who was in charge of the biosimilar's Phase 3 clinical trials.
"Treatment opportunities for many patients and contribution to fiscal savings are now possible," a bio industry source said.