Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups INCHEON, Korea, May .
EPYSQLI, a biosimilar referencing Soliris1 (eculizumab), is Samsung Bioepis' first biosimilar in hematology to be recommended for marketing authorization by the European Medicines Agency INCHEON, Korea
Phase 3 study demonstrated clinical equivalence in efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 compared to reference eculizumab in paroxysmal nocturnal hemoglobinuria
Investegate announcements from Samsung Bioepis, Samsung Bioepis Presents New Phase 3 Study of SB12 (Eculizumab), A Proposed Biosimilar to Soliris, at the European Hematology Association (EHA) Congress 2022