84 articles about Samsung Bioepis
Cambridge, Massachusetts-based Biogen exercised its option to acquire additional shares of Samsung Bioepis, a joint venture with Samsung BioLogics that was founded in 2012.
Samsung Bioepis and Biogen Announce Pooled Analysis Results of Anti-TNF Biosimilars BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab) at EULAR 2018
Samsung Bioepis Co., Ltd. and Biogen today announced pooled analysis results of three anti-tumor necrosis factor (anti-TNF) biosimilars – BENEPALI™ (SB4, etanercept biosimilar), FLIXABI™ (SB2, infliximab biosimilar), and IMRALDI™ (SB5, adalimumab biosimilar).
Samsung Bioepis Announces Results of Additional One-Year Follow-up Study on SB3 Trastuzumab Biosimilar Candidate at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
Additional one-year follow-up study results show low incidence of cardiac safety events and no statistically significant difference in survival results compared to reference trastuzumab in the SB3 treatment group
Strong Sales of Humira, Imbruvica and HCV Drug Mavyret Drive AbbVie’s Strong First Quarter
4/27/2018Humira, the world’s best-selling drug, keeps on churning out positive sales results for AbbVie, despite looming challenges.
Biogen and Samsung Bioepis Agree to Settlement with AbbVie Allowing Commercialization of IMRALDI™ (Adalimumab Biosimilar) in Europe
Biogen expects to launch IMRALDI in Europe on October 16, 2018
U.S. sales of AbbVie’s blockbuster Humira is safe from a biosimilar challenge from Samsung Bioepis, a joint project between Samsung and Biogen, until 2023.
Samsung Bioepis' SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration
Samsung Bioepis today announced that the FDA has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin (trastuzumab).
Samsung Bioepis Receives Regulatory Approval for Europe's First Trastuzumab Biosimilar, ONTRUZANT
Samsung Bioepis sets an industry record by obtaining European regulatory approval for four biosimilars in just two years.
Samsung Bioepis First To Receive Positive CHMP Opinion On A Trastuzumab Biosimilar With ONTRUZANT
Samsung Bioepis First To Obtain European Commission (EC) Approval For A Third Anti-TNF-? Biosimilar With Imraldi (Adalimumab)
Samsung Bioepis Forms Novel Biologics JV With Takeda Pharmaceuticals
Samsung Bioepis Announces RENFLEXIS (Infliximab-Abda) Now Available In The United States
Samsung Bioepis Emerging as a Strong Player in the Autoimmune Space
Samsung Bioepis' Imraldi (Adalimumab) Recommended For Approval By EMA
Samsung Bioepis Obtains First Drug Approval In The United States, As FDA Approves RENFLEXIS (Infliximab-Abda) Across All Eligible Indications
Samsung Bioepis’ Type II Variation Application For Indication Extension Of Benepali Receives Positive CHMP Opinion
Samsung Bioepis' Marketing Authorization Application For SB3 Trastuzumab Biosimilar Candidate Accepted For Review By EMA
Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar To Receive Regulatory Approval In Canada
Samsung Bioepis' Marketing Authorization Application For SB5 Adalimumab Biosimilar Candidate Accepted For Review By European Medicines Agency
Samsung Bioepis Announces New Data On Three Anti-TNF--a Biosimilar Molecules At The Annual European Congress On Rheumatology (EULAR 2016)