84 articles about Samsung Bioepis
Samsung Bioepis Continues Global Expansion, Enters Brazilian Biopharmaceutical Market with BRENZYS™ (etanercept)
Samsung Bioepis’ BRENZYS™ becomes available in Brazil through Brazil’s public health system, Sistema Único de Saúde
FDA Approves Samsung Bioepis' HADLIMA™ (adalimumab-bwwd)
Samsung Bioepis Co., Ltd. announced that the US Food and Drug Administration has approved HADLIMA™, a biosimilar referencing HUMIRA® i, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
Despite the approval, Samsung Bioepis' Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
FDA Approves ETICOVO™ (etanercept-ykro), Samsung Bioepis' Second Anti-TNF Medicine in the United States
Samsung Bioepis expands autoimmune portfolio in the United States with FDA approval of ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL®i (etanercept).
Samsung Bioepis Announces Three-year Follow-up Data for Biosimilar ONTRUZANT® (trastuzumab) in Early or Locally Advanced HER2-positive Breast Cancer
Three-year follow-up data show comparable overall survival between biosimilar ONTRUZANT® (trastuzumab) and reference medicine HERCEPTIN®i (trastuzumab)ii in early and locally advanced HER2-positive breast cancer
The United Food and Commercial Workers Local 1500 (UFCW Local 1500) filed a class action lawsuit against AbbVie for allegedly using a group of patents to maintain a monopoly on its blockbuster Humira (adalimumab).
Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China
Agreement covers Samsung Bioepis’ third-wave biosimilar candidates SB11 and SB12, which reference LUCENTIS® 1 (ranibizumab) and SOLIRIS® 2 (eculizumab), respectively
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® 1 (trastuzumab)
3SBio and Samsung Bioepis enter biosimilar collaboration agreement
3SBio Inc. announced today that it has entered into a collaboration agreement with Samsung Bioepis Co., Ltd. for the clinical development and commercialization of multiple biosimilar candidates developed by Samsung Bioepis, including SB8 Bevacizumab biosimilar candidate ("SB8") in Mainland China (excluding Hong Kong, Macau and Taiwan).
Samsung Bioepis Partners with 3SBio to Expand Biosimilar Business into China
Samsung Bioepis’ rapidly growing biosimilar business to expand into Chinese market through partnership with 3SBio, bringing together Samsung Bioepis’ proven development platform with 3SBio’s strong commercialization platform
Samsung Bioepis Announces Results of Additional One-Year Follow-Up Study Comparing Event-Free Survival of SB3 Trastuzumab Biosimilar Candidate to Reference Trastuzumab by ADCC Activity
Samsung Bioepis Co., Ltd. today announced the results of an additional one-year follow-up study comparing event-free survival (EFS) of SB3, a biosimilar candidate referencing HERCEPTIN® 1 (trastuzumab), to reference trastuzumab (TRZ) by antibody-dependent cell-mediated cytotoxicity (ADCC) activity.
Boston Business Journal recently created a list of 15 Massachusetts life science companies that in their third-quarter reports, allocated the highest percentage of total costs to research and development. Here’s a look.
Cambridge, Mass.-based Biogen exercised its option to acquire additional shares of South Korea’s Samsung Bioepis. Samsung Bioepis focuses on developing biosimilar drugs and is a joint venture between Samsung Biologics and Biogen formed in 2012.
The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.
Biogen and Samsung Bioepis Announce European Launch of IMRALDI™(adalimumab), Solidifying Leadership in European Anti-TNF Market
IMRALDITM (adalimumab), a biosimilar referencing HUMIRA® i, is the third anti-TNF biosimilar developed by Samsung
AbbVie’s Humira is the world’s best-selling drug that generated more than $18 billion for the Illinois-based company last year. This week though, the company will begin to see challenges to Humira in Europe from biosimilars developed by Amgen and Novartis, as well as others.
Samsung Bioepis' Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the U.S. Food and Drug Administration
The Biologics License Application for SB5 was based on a 52-week Phase 3 study comparing SB5 to the adalimumab reference product
Samsung Bioepis to Initiate Phase 1 Clinical Trial of SB26 Ulinastatin-Fc Fusion Protein
SB26, also known as TAK-671, is intended to treat severe acute pancreatitis
AbbVie continues to do what it can to protect its Humira-driven revenue stream. This morning the company inked an agreement to grant Mylan the rights to begin marketing its biosimilar to Humira in the United States in 2023.