Samsung Bioepis Receives EC’s Marketing Authorization for Epysqli (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Hemoglobinuria
Shots:
- The EC has granted marketing authorization for Epysqli, a biosimilar referencing Soliris (eculizumab) for the treatment of adult and children’s patients with PNH
- The approval was based on a totality of evidence incl. analytical, in vitro non-clinical data, and clinical data. The P-III study showed an equivalent clinical efficacy of Epysqli (first approved hematology biosimilar) over eculizumab after evaluating LDH in PNH patients
- Additionally, the company has seven biosimilars approved for use in the EU incl. Benepali, an anti-inflammatory biosimilar to Enbrel, and Imraldi, a biosimilar referencing Humira
Ref: Korea Biomed | Image: Samsung Bioepis
Related News:- Samsung Bioepis Reports P-III Study Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration
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