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
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com

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.