FDA Approves Samsung’s Eculizumab Biosimilar July 25, 2024 Emma Murray Alexion,Alexion v. Samsung (eculizumab),Amgen,BKEMV,eculizumab,Epysqli,Litigation,Regulatory,Samsung Bioepis,Soliris Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab bi...
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for eculizumab.Soliris (eculizumab) - Alexion Pharmaceuticals, Inc. Formulation typeStrength Single-Dose Vial 300 mg/30 mL (10 mg/mL) View Soliris information in ...