News Articles

Samsung Bioepis Continues Global Expansion, Enters Brazilian Biopharmaceutical Market with BRENZYS™ (etanercept) INCHEON, KOREA -Tuesday 10 September 2019

(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced its expansion into the Brazilian biopharmaceutical market. The first product available in the country is BRENZYS™ (etanercept), a biosimilar referencing ENBREL®.i BRENZYS™ was approved by Agência Nacional de Vigilância Sanitária...

Samsung Bioepis' Marketing Authorization Application for SB3 Trastuzumab Biosimilar Candidate Accepted for Review by... -Tuesday 4 October 2016  

(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab). Herceptin® is a monoclonal antibody (mAb)...

Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada -Monday 12 September 2016  

(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced that BRENZYS™ – a biosimilar referencing Enbrel® (etanercept), also known as SB4 – received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. BRENZYS™ will be commercialized...

Samsung Bioepis' Marketing Authorization Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by... -Monday 18 July 2016  

If approved, SB5, a biosimilar candidate referencing Humira® (adalimumab), will be Samsung Bioepis’ third anti-TNF-α biosimilar in Europe The Marketing Authorization Application for SB5 was based on a 52-week Phase III study which showed SB5’s comparable efficacy and safety to...

Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on... -Wednesday 8 June 2016  

  ↵ Long-term data shows Benepali® (etanercept) and Flixabi® (infliximab) sustain comparable efficacy and safety profiles to etanercept and infliximab reference products up to Week 100 and Week 78, respectively In one-year Phase III study, SB5 (adalimumab) investigational...

Samsung Bioepis Becomes First to Obtain European Commission Approval for Second Anti-TNF-α Biosimilar with Flixabi® -Monday 30 May 2016  

Samsung Bioepis solidifies industry leadership in biosimilars by becoming the first company to bring a second anti-TNF-α biosimilar to market Flixabi® is Samsung Bioepis’ second anti-TNF-α biosimilar to receive European Commission approval, following Benepali®, the first-ever...

Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug... -Tuesday 24 May 2016  

(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade® (infliximab), for the treatment of rheumatoid...

Samsung Bioepis' Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union -Saturday 2 April 2016  

Samsung Bioepis’ Flixabi® receives positive opinion from the Committee for Medicinal Products for Human Use, meets the European Medicines Agency’s requirements on the quality, efficacy and safety of biosimilars Flixabi® becomes the second anti-TNF-α biosimilar developed by Samsung...

Samsung Bioepis Enters the European Biopharmaceutical Market with Benepali®, the First Fusion Protein Biosimilar... -Sunday 17 January 2016  

In just under four years, Samsung Bioepis develops, tests and receives regulatory approval for Benepali®, the first etanercept biosimilar in the European Union The European Commission approval applies to all 28 European Union member states as well as the European Economic Area member...