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| ▲ The photo, provided by Samsung Bioepis Co., shows the company's logo. (PHOTO NOT FOR SALE) (Yonhap) |
drugmaker-European approval
Samsung Bioepis' hematology biosimilar wins marketing approval in Europe
SEOUL, May 30 (Yonhap) -- Samsung Bioepis Co., a biosimilar medicine producer under Samsung Group, said Tuesday its hematology biosimilar has won marketing approval from Europe's medicine authorities.
The European Commission (EC) granted marketing authorization for Epysqli, a biosimilar referencing Soliris (eculizumab), for the treatment of adult and child patients with paroxysmal nocturnal hemoglobinuria (PNH), according to the company.
PNH is a rare disease where red blood cells break apart prematurely.
The drug became Samsung Bioepis' first approved hematology biosimilar, helping the company further expand its biosimilars portfolio, said the company.
The approval came two months after the European Medicines Agency had adopted a positive opinion for Epysqli in March, which is considered a prerequisite for the final EC decision.
Adding Epysqli, Samsung Bioepis now has seven biosimilars approved for use in Europe, including Benepali (etanercept), an anti-inflammatory biosimilar to Enbrel, and Imraldi (adalimumab), a biosimilar referencing Humira.
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