Tagged as: Samsung Bioepis

Senators Ask FTC To Examine Biosimilar Patent Settlements For Antitrust Violations

United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.”  According to the Senators, “biologics constitute a…

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Samsung Bioepis and Biogen Announce Pooled Analysis of Three Anti-TNF Biosimilars

Yesterday, Samsung Bioepis and Biogen announced pooled analysis results that will be presented this week at the 2018 Annual European Congress of Rheumatology (EULAR). Data from three separate Phase III randomized, double-blinded studies compared the safety and efficacy of BENEPALI (SB4, etanercept biosimilar); FLIXABI (SB2, infliximab biosimilar); and IMRALDI (SB5,…

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Samsung Bioepis Reports One-Year Follow-Up Results for Trastuzumab Biosimilar

According to an announcement by Samsung Bioepis, an additional one-year follow-up study on SB3, a biosimilar candidate referencing Herceptin® (trastuzumab), showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to trastuzumab in patients with HER2-positive early or locally advanced breast cancer. The data…

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AbbVie Reports Positive Phase 3 Results Showing Small Molecule Upadacitinib Is Superior To Adalimumab For RA

AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…

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AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for its commercialization in all approved markets worldwide.  SB5 has already received marketing authorization from the European Commission (EC) as…

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Samsung Bioepis’s Etanercept Biosimilar Said to be Less Immunogenic than Enbrel

A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and reference etanercept (Enbrel), SB4 has been found to be less immunogenic than reference etanercept.  The letter notes that injection site…

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