Business Wire (01/16/16)

The European Commission (EC) has granted approval to Benepali, an etanercept biosimilar referencing Enbrel that was developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics. Benepali has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis. Benepali is the first subcutaneous anti-TNF biosimilar available in the EU. 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 I and Phase III clinical trials compared Benepali to its reference product Enbrel. A 52-week, double-blind, Phase III 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 at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8 percent in the Benepali arm versus 81.5 percent in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel throughout the study.

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