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
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