Simcere, Amgen to bring in 4 biosimilars to China

Chinese pharmaceutical firm, Simcere, has inked an exclusive agreement with Amgen to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology and are a part of Amgen's existing biosimilars portfolio.

As per the terms, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote the products.

Specific financial terms of the agreement were not disclosed.

Mr Scott Foraker, vice president and general manager of Biosimilars at Amgen, said, ""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."

"This agreement furthers Amgen's efforts to reach more patients in Asiaby bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions," said Penny Wan, regional vice president and general manager of Amgen's Japan and Asia-Pacific Region. "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."

"This strategic partnership between a world-renowned biotechnology company and a leading Chinese pharma will help to accelerate development and launch of United States and European approved biosimilars in China. By leveraging our sales network, it will also help to improve the accessibility of high quality therapeutic antibodies for Chinese patients," said Honggang Feng, president of Simcere. "This collaboration will allow both companies to further penetrate inflammation and oncology markets in China."

Dr. 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. It is also another important milestone in our international collaboration strategy to enrich Simcere's biologics pipeline."

Simcere is a research and development-driven Chinese pharmaceutical company, focussing its efforts on therapeutic areas of oncology, neurology, inflammation/immunology, cardiovascular and infectious diseases.