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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of Samsung Bioepis' Benepali, an investigational treatment developed as a biosimilar version of Amgen's Enbrel arthritis drug.
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Samsung Bioepis is the joint venture between Samsung Biologics and Biogen.
Benepali (etanercept) is indicated to treat severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis.
The CHMP’s positive opinion was based on a preclinical and clinical data package comparing Benepali to Enbrel.
Under a 52-week, double-blind, Phase 3 study, 596 patients were randomized with moderate to severe RA despite methotrexate therapy across 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio.
Results showed an ACR20 response rate of 80.8% in the Benepali arm, compared to 81.5% in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel.
Biogen vice president and global head of the biosimilars business unit Alpna Seth said: "The positive CHMP recommendation for Benepali is a great step forward for patients, physicians and payers in Europe.
"Biosimilars have the potential to help improve access to important biologic treatments for those who need them most."
If approved, Benepali could be the first biosimilar of Enbrel and the first subcutaneous anti-TNF biosimilar in the European Union.