Type of information: Development agreement
Compound: biosimilar forms of etanercept (CHS-0214 ) and rituximab
Company: Coherus Biosciences (USA - CA) Daiichi Sankyo (Japan)
Type agreement: development - commercialisation
- • On May 7, 2012, Coherus BioSciences and Daiichi Sankyo announced the execution of an exclusive agreement to develop and commercialize biosimilar forms of etanercept and rituximab in certain Asian countries including Japan.
- Under the terms of the agreement, Daiichi Sankyo and Coherus BioSciences will work together to develop, manufacture and commercialize biosimilar forms of etanercept and rituximab developed by Coherus BioSciences. Upon marketing approval, Daiichi Sankyo will commercialize these products in Japan, South Korea and Taiwan. Coherus has retained all additional development and commercial rights outside of the licensed territories.
Financial terms: Specific financial terms of the agreement were not disclosed.
- • On July 5, 2017, Daiichi Sankyo 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.
- 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.