Samsung Bioepis

84 articles about Samsung Bioepis

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  Biogen Increases Ownership in Samsung Bioepis

  6/29/2018

  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

  6/13/2018

  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

  6/1/2018

  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

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  Strong Sales of Humira, Imbruvica and HCV Drug Mavyret Drive AbbVie’s Strong First Quarter

  4/27/2018

  Humira, 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

  4/5/2018

  Biogen expects to launch IMRALDI in Europe on October 16, 2018

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  AbbVie Strikes Deal: Blockbuster Humira is Safe Until 2023

  4/5/2018

  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

  12/20/2017

  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

  11/20/2017

  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

  9/15/2017

• Samsung Bioepis First To Obtain European Commission (EC) Approval For A Third Anti-TNF-? Biosimilar With Imraldi (Adalimumab)

  8/25/2017

• Samsung Bioepis Forms Novel Biologics JV With Takeda Pharmaceuticals

  8/23/2017

• Samsung Bioepis Announces RENFLEXIS (Infliximab-Abda) Now Available In The United States

  7/24/2017

• Samsung Bioepis Emerging as a Strong Player in the Autoimmune Space

  7/20/2017

• Samsung Bioepis' Imraldi (Adalimumab) Recommended For Approval By EMA

  6/23/2017

• Samsung Bioepis Obtains First Drug Approval In The United States, As FDA Approves RENFLEXIS (Infliximab-Abda) Across All Eligible Indications

  4/24/2017

• Samsung Bioepis’ Type II Variation Application For Indication Extension Of Benepali Receives Positive CHMP Opinion

  12/19/2016

• Samsung Bioepis' Marketing Authorization Application For SB3 Trastuzumab Biosimilar Candidate Accepted For Review By EMA

  10/4/2016

• Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar To Receive Regulatory Approval In Canada

  9/12/2016

• Samsung Bioepis' Marketing Authorization Application For SB5 Adalimumab Biosimilar Candidate Accepted For Review By European Medicines Agency

  7/18/2016

• Samsung Bioepis Announces New Data On Three Anti-TNF--a Biosimilar Molecules At The Annual European Congress On Rheumatology (EULAR 2016)

  6/8/2016