Latest News and Press Releases

Final 56-week results from the Phase 3 study for SB15 compared with reference aflibercept in neovascular age-related macular degeneration to be presented, in addition to analytical similarity data...

To be published on quarterly basis, with updated average sales price (ASP) and National Average Drug Acquisition Cost (NADAC) trendsBiosimilars continue to play a crucial role in driving down...

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,...

SB17 (ustekinumab) is Samsung Bioepis’s fourth biosimilar candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab), and SB5 (adalimumab)Phase 1 study demonstrated...

With the approval, Samsung Bioepis has both low (40mg/0.8mL) and high (40 mg/0.4mL) concentration of adalimumab biosimilar approved in CanadaReaffirms its commitment to increasing accessibility by...

Recognized and awarded for its leadership and expertise in biosimilars – following 2020 Biosimilar Initiative of the Year awardAlso shortlisted as finalists in Company of the Year, Regulatory...

SB15, a proposed biosimilar to EYLEA, showed equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics profile to reference aflibercept in the Phase 3 study interim analysisA...

Obtains ISO 14001 (Environmental Management System) and ISO 50001 (Energy Management System)Recognized for continuous practices and commitment to enhancing sustainability management INCHEON, Korea,...

Long term follow-up data from British Association of Dermatologics and Immunomodulators Register (BADBIR) shows safety and effectiveness of SB5 in patients with psoriasis who have started or...

Phase 3 study demonstrated clinical equivalence in efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 compared to reference eculizumab in paroxysmal nocturnal...