TOKYO, Japan (January 12, 2016) – Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) today announced that they have achieved major objectives in the Phase 3 international joint trial (RApsody) of CHS-0214, an investigational etanercept (genetical recombination) biosimilar*1 in rheumatoid arthritis (RA) under development with the U.S. company, Coherus BioSciences, Inc. (hereinafter, Coherus).
The trial compares the efficacy and safety of CHS-0214 with Enbrel® [generic name: etanercept (genetical recombination); hereinafter, reference product] in RA patients (including Japanese patients) with inadequate response to methotrexate.
The primary endpoint (ACR20*2), evaluating the disease activity of rheumatoid arthritis at 24 weeks after the administration of CHS-0214, met the criteria of equivalence as defined in advance in CHS-0214 and reference product groups, achieving the intended purpose. No significant difference was noted in the reported adverse events between CHS-0214 and reference product groups. Currently, this trial is continued in open-label extension study following the 24-week double-blind phase.
Daiichi Sankyo will continue the development of CHS-0214 based on the strategic alliance with Coherus, concluded for the biosimilar business in Japan in 2012, aiming to enter the biosimilar market to meet diverse medical needs.