Amgen Partners With Simcere to Commercialize Biosimilars in China

Drug maker Amgen has announced a deal to partner with Simcere Pharmaceutical Group to co-develop and commercialize 4 biosimilar treatments in China.

Under the agreement, Amgen will be responsible for the co-development, market approval applications, and manufacturing of the biosimilars. Simcere, meanwhile, will distribute and commercialize the drugs in China.

"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.”

While 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.

China has recently begun to implement significant changes in its regulatory and policy positions on medicines; the China Food and Drug Administration joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)—a not-for-profit entity established under Swiss law to promote international alignment of regulatory authorities—and has tightened its regulation of drugs.

Additionally, in February, the Chinese government updated its list of medicines covered by basic insurance for the first time in 8 years to increase patient access. According to Reuters, patients in China are often forced to resort to “gray markets” to buy cheaper treatments for major illnesses, and the update of the list, which includes 2535 drugs (1297 of them Western drugs) is expected to make high-cost medicines more accessible to the patients who need them. Drugs appearing on the government’s list can be reimbursed up to 80% of their cost.

The Chinese government is also negotiating with drug makers over a confidential list of 45 treatments that have significant therapeutic value but are too expensive for inclusion in the reimbursement scheme. Some analysts suggest that rituximab, trastuzumab, bevacizumab, infliximab, and adalimumab are likely to be on the negotiation list, a scenario that would provide a biosimilar developer with a potential advantage in securing a place on the national formulary.