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  • Samsung Bioepis, Soliris biosimilar approved in Europe
  • by Chon, Seung-Hyun | translator Kim, Jung-Ju | May 31, 2023 05:36am
Final approval of Episcli for treatment of rare diseases such as nocturnal hemoglobinuria
First biosimilar in hematology
 ¡ã A view of Samsung Bioepis headquarters
Samsung Bioepis announced on the 30th that it has obtained item permission from EC for Episcli, a biosimilar of Soliris, a treatment for rare diseases. On March 30, after obtaining a positive opinion for sales approval from CHMP under the EMA, the final approval was obtained two months later. Episcli is the first biopharmaceutical in hematology developed by Samsung Bioepis. Soliris is an ultra-expensive drug developed by Alexion of the US that is used for intractable rare diseases such as nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Last year, global sales amounted to about 5 trillion won.

Samsung Bioepis demonstrated pharmacokinetic equivalence between Episcli and the original drug in phase 1 c
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