Shots:
- The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab)
- Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris
- Epysqli is intended for treating paroxysmal nocturnal hemoglobinuria (PNH) for reducing hemolysis and atypical hemolytic uremic syndrome (aHUS) for inhibiting complement-mediated thrombotic microangiopathy
Ref: Samsung Bioepis | Image: Samsung Bioepis| Press Release
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