Amgen and Simcere announce collaboration in the development and distribution of biosimilars in China
An exclusive agreement has been reached by Amgen (CA, USA) and Simcere (Jiangsu, China) in the co-development and commerce of four undisclosed oncology and inflammation biosimilars, currently part of Amgen’s existing portfolio.
Whilst specific details of the agreement have not been disclosed, it has been announced that Amgen will maintain responsibility for the co-development, marketing approval applications and manufacturing of the biosimilars and that Simcere will be taking responsibility for the distribution and commercialization in China. Amgen will have limited ability to co-promote the products.
Scott Foraker, vice president and general manager of Biosimilars (Amgen), commented: “We are pleased to enter this strategic collaboration with Simcere as we continue to enhance patient access through broader adoption of more competitive therapeutic options worldwide. This agreement brings together Amgen’s long-standing development and biologics manufacturing expertise with Simcere’s local development experience and strong commercial presence in China in the areas of inflammation and oncology.”
Penny Wan regional vice president (Amgen) further remarked, “This agreement furthers Amgen’s efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions. We look forward to working with Simcere on these four biosimilar programs where we can build on their network and experience in China to make a big difference for patients.”
Hua Mu chief scientific officer (Simcere) concluded, “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. It is also another important milestone in our international collaboration strategy to enrich Simcere’s biologics pipeline.”
