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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
