Amgen to Develop Four Biosimilars in China

On Sep. 26, 2017, Amgen announced an exclusive agreement with Simcere Pharmaceutical Group, a R&D-driven Chinese pharmaceutical company, to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.

Under the agreement, Amgen will remain responsible for 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. The biosimilars included in the agreement are a part of Amgen's existing biosimilars portfolio. Specific financial terms of the agreement were not disclosed.

"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," said Penny Wan, regional vice president and general manager of Amgen's Japan and Asia-Pacific Region, in a company press release. "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, in the press release. "This collaboration will allow both companies to further penetrate inflammation and oncology markets in China."

Recently, China Food and Drug Administration formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The agency has also recently implemented major reforms on drug evaluation and approval systems to encourage and support research into and development of innovative, high quality medicines.

Source: Amgen