CFDA’s New Policy Accelerated Amgen-Simcere Strategic Alliance

On 12th October, Amgen, the largest biopharmaceutical company in the world, and Simcere’s strategic alliance press conference was held in Nanjing. This alliance is the collaboration between Amgen and Simcere regarding several product portfolios. Simcere will bring four biosimilars of Amgen to China, which created the first cooperation in the industry with such a scale and form.

This alliance has also received approval and support from Jiangsu provincial party leader, who said this was an innovative international strategic collaboration, serving as a model for businesses in Jiangsu to open up and collaborate to promote innovation.


Unlike the usual business cooperation, Amgen and Simcere co-develop and commercialize four biosimilars with the same strategic goal, mission and values. A special team for the alliance was established, attaching importance to information flow and sharing. Both parties utilize fully their advantages and skills to share benefits and risks.

Among the four biosimilars, Amgevita, a medicine for rheumatoid diseases, and Mvasi, a drug for cancer have both been approved by FDA, respectively in September last year and September this year.

On 8th October, CFDA announced its new policy on promoting drug and medical device innovation. And supporting biosimilars and improving the accessibility of high quality biomedicines is one important aspect of the new policy.


Ruilin Song, the executive president of China Pharmaceutical Innovation and Research Development Association (PhIRDA), said to some extent, it was the new CFDA policies that accelerated this strategic alliance.

Other industrial vets also attended the press conference and expressed their support and approval for Amgen-Simcere strategic alliance.




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