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Samsung Bioepis’ Biosimilar to Enbrel Wins EU Approval

Biogen will lead commercialization and distribution across all 28 EU member states, Norway, Iceland and Liechtenstein

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By: Kristin Brooks

Managing Editor, Contract Pharma

Samsung Bioepis Co. received approval from the European Commission for Benepali, a biosimilar to Amgen’s Enbrel (etanercept), for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. In a 52-week Phase III study, Benepali demonstrated comparable safety and equivalent efficacy to Enbrel, with a ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm. Benepali will be marketed across all 28 European Union (EU) mem...

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