Tokyo-based Daiichi Sankyo and U.S.-based Coherus Biosciences ($CHRS) hit a successful Phase III mark in trials for a biosimilar of Amgen's ($AMGN) rheumatoid arthritis therapy Enbrel.
The Japanese company said last week it had "achieved major objectives in the Phase III international joint trial (RApsody) of CHS-0214, an investigational etanercept (genetical recombination) biosimilar."
"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."
Over the weekend, South Korea's Samsung Bioepis said it won European Commission approval for commercial sales of a Enbrel biosimilar, marking a first that will make its version of the rheumatoid arthritis treatment available across the European Union as well as in Norway, Iceland and Liechtenstein.
If approved locally, the candidate would mark the first biosimilar for etanercept in Japan and could come as early as 2017. The market for biosimilars in Japan is on the upswing with Remicade, Neupogen and insulin glargine versions among a half-dozen biosimilars in total approved by the Japan Pharmaceutical and Medical Devices Agency in the past few years.
Under the terms of a 2012 collaboration deal between Daiichi and Coherus, the two firms agreed to develop and market the Enbrel biosimilar and a biosimilar of Roche's ($RHHBY) Rituxan.
In the agreement, Daiichi covers Japan and Taiwan, as well as what would be a likely tough market in South Korea, with other global rights held by Coherus, which it would share in part with Baxter International ($BAX).
- here's the release from Daiichi Sankyo