Daiichi Sankyo initiates testing of etanercept biosimilar in Japan

Japanese drug major Daiichi Sankyo (TYO: 4568) says it has started the Phase III trial of CHS-0214, an investigational etanercept biosimilar, in rheumatoid arthritis (the RApsody trial) in Japan. Daiichi Sankyo is a co-sponsor of this trial, in collaboration with the US biopharmaceutical company Coherus BioSciences.

The trial is a randomized, double-blind, active-control, parallel-group, multicenter, global study, comparing the efficacy and safety of CHS-0214 with Enbrel (from Amgen; Nasdaq: AMGN) in subjects with active rheumatoid arthritis (RA) who have demonstrated an inadequate response to methotrexate. The primary endpoint is ACR 20* at 24 weeks. Daiichi Sankyo is developing CHS-0214 in Japan with the intention to enter the biosimilar market in the near future.

Biosimilars (also known in Japan as bio-kozokuhin or “follow-on biologics”) are biologic medical products that are similar to already approved biotechnology applied pharmaceuticals but are developed by a different manufacturer.