胰岛素国家专项集中采购政策的实施与思考

Practice and Consideration of Insulin National Centralized Procurement Policy

国家医疗保障局已开展并执行6批7轮药品集中带量采购工作,其中,第6批胰岛素专项采购是我国首次将采购领域由化学药拓展至生物药。通过梳理国家组织药品集中采购历程,简述我国生物类似物审批监管流程现状,分析武汉胰岛素集中采购试点以及胰岛素国家专项集中采购政策要点和实践结果,为国家药品集中采购常态化、制度化以及生物药领域国家带量采购提供相关政策思考和建议。

The national healthcare security administration has carried out six batches and seven rounds of drug centralized volume-based procurement(VBP).The sixth batch of insulin procurement is the first time that national volume-based procurement(NVBP) has expanded the field from chemical drugs to biopharmaceuticals.It intends to review the process of national drug volume-based procurement,briefly describe the current national regulation and approval of biosimilar drugs,analyze the policy and results of both Insulin Wuhan VBP and Insulin NVBP,and finally provide relevant policy thinking and suggestions for national volume-based procurement in the field of biopharmaceuticals.