Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)
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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
