2020년 4월 16일 09:25

Samsung Bioepis Announces US Launch of ONTRUZANT® (trastuzumab-dttb) for Early and Metastatic HER2-overexpressing Breast Cancer and Metastatic Gastric Cancer

Samsung Bioepis Co., Ltd. announced today that ONTRUZANT® (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN®[1] (trastuzumab) for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metasta...

2019년 11월 7일 15:48

Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates

Samsung Bioepis Co., Ltd. announced today that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the U...

2019년 10월 10일 10:48

Samsung Bioepis Presents Real-world Data of BENEPALI™ (etanercept) in Patients with Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

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 ...

2019년 9월 27일 11:13

Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar Candidate, at the European Society for Medical Oncology (ESMO) 2019 Congress

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-sma...

2016년 10월 4일 11:45

Samsung Bioepis' Marketing Authorization Application for SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the European Medicines Agency

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 ...

2016년 9월 13일 11:25

Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada

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...

2016년 7월 18일 11:15

Samsung Bioepis' Marketing Authorization Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the European Medicines Agency

Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB5, a biosimilar candidate referencing Humira® (adalimumab). SB5 is Samsung Bio...

2016년 6월 9일 09:15

Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016)

Samsung Bioepis Co., Ltd. today announced new clinical data on its anti-TNF-α portfolio of Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate. The data will be presented through seven poster pre...

2016년 5월 30일 13:55

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

Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Flixabi® - a biosimilar version of Remicade® (infliximab), also known as SB2 - for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ank...

2016년 5월 24일 10:10

Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration

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 treatm...

2016년 4월 4일 09:00

Samsung Bioepis' Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union

Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi® - a biosimilar version of Remicade® (infliximab), also known as S...

2016년 1월 18일 09:20

Samsung Bioepis Enters the European Biopharmaceutical Market with Benepali®, the First Fusion Protein Biosimilar Approved by the European Commission

Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Benepali® - a biosimilar referencing Enbrel® (etanercept), also known as SB4 - for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthr...

2015년 12월 7일 09:30

Samsung Bioepis' RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea

Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® - a biosimilar version of Remicade® (infliximab), also known as SB2 - for the treatment of rheumatoid arthritis, ankylosing spon...

2015년 11월 23일 10:15

Samsung Bioepis Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union

Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali® - a biosimilar version of Enbrel® (etanercept), previously known...