The new agreement covers four biosimilars.
In order to gain better access to the Chinese market. Amgen released that it is partnering with Nanjing-based pharmaceutical firm Simcere Pharmaceutical Group to exclusively co-develop and commercialize four biosimilars from Amgen in inflammation and oncology, including ABP 501, Mvasi (bevacizumab-awwb, ABP 215) and ABP 980.
ABP 501 is a biosimilar of Abbvie’s branded monoclonal antibody (mAb) drug Humira (adalimumab) that targets tumor necrosis factor (TNF) alpha. ABP 501 is approved in the US as Amjevita (adalimumab-atto) and in the EU as Amgevita and Solymbic. Mvasi, Amgen’s biosoimilar of Roche/Genentech’s Avastin (bevacizumab) received FDA approval in September 2017. It is a humanized mAb that targets vascular endothelial growth factor (VEGF). ABP 980 is a biosimilar of Roche's humanized mAb trastuzumab, which targets Herceptin that is currently under review in the U.S. and EU.
Amgen has been present in China since 2012 and has a presence in Shanghai and Beijing. Amgen-Betta Pharmaceuticals Co. Ltd. was formed in 2013 with Betta Pharmaceuticals Co. Ltd. commercialize Amgen's colorectal cancer drug Vectibix panitumumab. The company opened an Asia R&D Center in 2014 in Zhangjiang Hi-Tech Park in Shanghai.
The deal, according to Amgen, will allow the company to benefit from Simcere’s drug development experience in China and its "strong commercial presence” in the country, particularly in inflammation and oncology. Simcere will benefit from an expanded pipeline. The company also indicated that the decision to partner with Amgen was in part due to the fact that China FDA joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which will enable the development and implementation of international standards, guidelines and rules in China, and allow Chinese manufacturers to compete internationally.
Amgen will handle all regulatory aspects and manufacturing and have limited co-promotion rights, with Simcere responsible for commercializing the biosimilars in China. Financial terms of the deal were not disclosed.