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The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission approval for BENEPALI, an etanercept biosimilar referencing Enbrel

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Additional Relevant Details The EC approval was based on a robust preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development and manufacturing expertise. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared BENEPALI to its reference product Enbrel.iii, iv The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive BENEPALI or Enbrel in a 1:1 ratio. Analysis of the primary endpoint showed that BENEPALI had equivalent efficacy to Enbrel, as shown by an ACR20 response at week 24 of 78.1% in the BENEPALI arm versus 80.3% in the Enbrel arm. Further analysis at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8% in the BENEPALI arm versus 81.5% in the Enbrel arm. The safety profile of BENEPALI was comparable to that of Enbrel throughout the study.
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Occurred on:
Jan 16, 2016
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Related Keywords Joint Venture, European Commission Approval, Ec, Etanercept, Biosimilar, Enbrel, Severe Rheumatoid Arthritis, Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, Plaque Psoriasis, Subcutaneous Anti-tnf Biosimilar, Chronic Inflammatory Conditions