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For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Sunao Manabe, Representative Director, President and COO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Daiichi Sankyo Announces Discontinuation of Etanercept Biosimilar (CHS-0214) Development in Japan
Tokyo, Japan (July 5, 2017) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has decided to discontinue the development of CHS-0214 in Japan, an investigational etanercept biosimilar* in rheumatoid arthritis conducted with the U.S. company, Coherus BioSciences, Inc.
The primary endpoint, evaluating the disease activity of rheumatoid arthritis 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.
However, due to the fact that a commercial manufacturing process to enable the feasible supply of CHS-0214 in Japan cannot be established at this time, Daiichi Sankyo has decided to discontinue the development of CHS-0214 in Japan.
* Biosimilars are biologic medical products that are similar to already approved biotechnology applied pharmaceuticals in terms of quality, safety, and efficacy but are developed by a different manufacturer.