Amgen Announces Alliance With Simcere To Commercialize Biosimilars
US-based biotechnology company Amgen has now announced a strategic collaboration 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.
“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,” said Scott Foraker, vice president and general manager of Biosimilars at Amgen. “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.”
Under the partnership, the two companies will work together to develop undisclosed biosimilars in the areas of inflammation and oncology.
The agreement will be dictating the following- 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.
Simcere said the deal
will help enrich its pipeline as part of its international collaboration strategy and that the decision to partner with Amgen was based on China FDA joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). By joining ICH, CFDA said China’s regulators, industry and institutions will be able to both implement and develop international standards, guidelines and rules, which will promote the entry of innovative drugs into the Chinese market and foster the country’s ability to compete internationallyWhile Amgen and Simcere did not disclose the 4 biosimilars included in the deal, Amgen indicated that the drugs are part of its existing biosimilars portfolio. Amgen’s pipeline includes a number of biosimilar candidates: cetuximab, infliximab, rituximab, eculizumab, trastuzumab, and bevacizumab (the newly FDA-approved Mvasi). The company has also gained approval of its biosimilar adalimumab, Amjevita, which will be launched in the United States in 2023 (and in the European Union in 2018 under the name Amgevita) under a new settlement between Amgen and AbbVie, developer of the reference adalimumab, Humira.
“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.“
