Daiichi Sankyo initiates Phase 3 trial for etanercept biosimilar in Japan

August 21, 2014 7:32 AM

Daiichi Sankyo Company, Limited announced the start of the Phase 3 trial of CHS-0214, an investigational etanercept biosimilar, in rheumatoid arthritis (the RApsody trial) in Japan.

Daiichi Sankyo is the co-sponsor of this trial and the company is in collaboration with the U.S. company Coherus BioSciences, Inc. The trial is a randomized, double-blind, active-control, parallel-group, multicenter, global study, comparing the efficacy and safety of CHS-0214 with Enbrel in subjects with active 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.

Source: Daiichi Sankyo press release

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