Amgen and Simcere Pharmaceutical Group will together develop and commercialise four biosimilars in China under a new strategic collaboration.
Though undisclosed, the biosimilars from Amgen’s existing portfolio are in the arrears of inflammation and oncology.
Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars, with Simcere responsible for distribution and commercialisation in China.
Hua Mu, Chief Scientific Officer of Simcere, said: “Recently, China Food and Drug Administration (CFDA) has formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and implemented major reforms on drug evaluation and approval systems, encouraging and supporting research and development of innovative, high quality medicines.
“This strategic alliance combines Amgen’s leading global research and development capabilities in biosimilars and Simcere’s domestic drug development and registration experience.
“It aims to bring more high quality and effective medicines to Chinese patients to meet the pressing unmet medical needs.”