Daiichi Sankyo's Enbrel biosimilar meets Ph III endpoints

Japanese pharma major Daiichi Sankyo (TYO: 4568) says that the Phase III international joint trial (RApsody) of CHS-0214, an investigational Enbrel (etanercept [genetical recombination]) biosimilar in rheumatoid arthritis (RA) under development with the US company, Coherus BioSciences, has achieved its major objectives.

The trial compares the efficacy and safety of CHS-0214 with Enbrel (marketed by Amgen [Nadaq: AMGN] and Pfizer [NYSE: PFE]) in RA patients (including Japanese patients) with inadequate response to methotrexate.

The primary endpoint (ACR20), 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.