News Articles

Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates INCHEON, Korea. -Wednesday 6 November 2019

Agreement with Biogen covers Samsung Bioepis’ biosimilar candidates in pre-clinical and clinical development, which reference two widely-used biologic medicines in ophthalmology: ranibizumab and aflibercept Includes an option for Biogen to extend existing commercialization agreement for...

Samsung Bioepis Presents Real-world Data of BENEPALI™ (etanercept) in Patients with Psoriasis at European Academy... -Wednesday 9 October 2019

(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced real-world data of BENEPALI™ in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). The results will be presented at the 2019 European Academy of...

Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar Candidate, at the European Society for Medical... -Friday 27 September 2019

(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer...

Samsung Bioepis Continues Global Expansion, Enters Brazilian Biopharmaceutical Market with BRENZYS™ (etanercept) -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...

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