China's first bevalbed mono-biosimilar drug approved for sale

　　China's State Drug Administration announced on the 9th, Qilu Pharmaceutical Co., Ltd developed the Bevalbea mono-anti-injection (commodity name: Antoa) listing registration application was recently approved The drug is the first approved bebabazumab anti-biosimilar drug in China, mainly used in the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer according to the , bevalbezumab is a human-derived monoclonal antibody IgG1 prepared using recombinant DNA technology, which inhibits the binding of VEGF to its receptors by binding to human vascular endothelial growth factor (VEGF), blocking the signaling pathway stoisted by blood vessels and inhibiting the growth of cells As one of the important drugs against tumor angiogenesis, bevalazumab has been applied to the treatment of a variety of malignant tumors Medicines Network December 10th, the original research bevapearlie was included in China's national health insurance drug catalog through national price negotiations in 2017, but patients still spend about RMB 10,000 using a course of treatment, and high prices limit patient sacrifiability the State Drug Administration pointed out that the approved Bevalbeu mono-injection is declared by Qilu Pharmaceutical Co., Ltd., is China's first to the original research bevalbezumab as a reference drug, in accordance with the biological similar drug approach to research and development and declaration of production of products, access to the national "major new drug creation" science and technology major special support, the State Drug Administration in accordance with the priority review and approval procedures approved the listing of the variety The approval of this product will improve the accessibility of this type of and provide new options for the treatment of Chinese patients biosimilars and chemical generics fall into the generic category In 2015, China's State Drug Administration issued the Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial), which greatly promoted the development of local biosimilar drugs In 2017, Chinese officials issued a statement stressing that they should continue to encourage innovation and promote generic production of drugs, reduce the burden of drug use, and support the imitation of products such as biosimilars We will accelerate the consistent evaluation of the quality and efficacy of generic drugs (Complete)