国家基本药物目录视角下的过评仿制药分析  

Analysis of evaluated generic drugs from the perspective of the National Essential Medicine List

作　　者：王金石 赵紫楠[2] 李可欣[3] 张天齐 朱柏霖 纪立伟[2] 金鹏飞[2] 胡欣[2] 罗小峰[1] 赵飞 WANG Jin-shi;ZHAO Zi-nan;LI Ke-xin;ZHANG Tian-qi;ZHU Bo-lin;JI Li-wei;JIN Peng-fei;HU Xin;LUO Xiao-feng;ZHAO Fei(School of Public Health,Lanzhou University,Lanzhou 730000,China;Department of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation,Beijing 100730,China;Clinical Trial Research Center,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation,Beijing 100730,China)

机构地区：[1]兰州大学公共卫生学院,兰州730000 [2]北京医院药学部,国家老年医学中心、中国医学科学院老年医学研究院、药物临床风险与个体化应用评价北京市重点实验室,北京100730 [3]北京医院临床试验研究中心,国家老年医学中心、中国医学科学院老年医学研究院、药物临床风险与个体化应用评价北京市重点实验室,北京100730

出　　处：《临床药物治疗杂志》2024年第5期39-43,共5页Clinical Medication Journal

基　　金：国家卫生健康委员会医院管理研究所医院药学高质量发展研究项目(NIHAYS2332);北京市科技计划课题(Z191100007619038)。

摘　　要：目的探讨我国基本药物过评仿制药情况和重复仿制现状。方法搜集、整理国家药品监督管理局2017年8月1日至2023年9月1日公布的通过一致性评价的仿制药产品信息,统计分析过评仿制药的重复情况及其在2018年版《国家基本药物目录》中的分布与变化情况。结果共收集到来自不同厂家的7431个仿制药产品,2818个品规,1170个品种,涉及26种药理作用类别和41种剂型。438种基本药物中,135(30.8%)种全部品规有过评仿制药,104(23.7%)种部分品规有过评仿制药,199(45.4%)种品规无过评仿制药。基本药物共计1128个品规,614(54.4%)个品规无过评仿制药,514(45.6%)个品规有过评仿制药。326(63.4%)个品规的基本药物过评仿制药重复产品数为1~3个,79(15.4%)个品规的基本药物过评仿制药重复产品数为4~6个,109(21.2%)个品规的基本药物过评仿制药重复产品数≥7个。结论我国基本药物的仿制尚不均衡,部分基本药物过评仿制药过度重复仿制现象严重。Objective To explore the situation of generic drugs that have undergone consistency evaluation within Chi⁃na′s Essential Medicines and the prevalence of excessive replication among these generics.Methods Data on generic drugs that passed the consistency evaluation from August 12017 to September 12023 was collected from the National Medical Prod⁃ucts Administration.This data was analyzed to assess the excessive replication of these generics and examine their distribution and changes within the 2018 version of the National Essential Medicines List.Results A total of 7431 generic drug products from various manufacturers were collected,comprising 2818 specifications and 1170 varieties across 26 pharmacological cate⁃gories and 41 dosage forms.Of the 438 essential medicines,135(30.8%)had all specifications represented by evaluated ge⁃nerics,104(23.7%)had some,and 199(45.4%)had none.Of these,1128 specifications were analyzed,614(54.4%)of which had no evaluated generics,while 514(45.6%)did.Furthermore,326(63.4%)specifications had 1 to 3 redundant evaluated products,79(15.4%)had 4 to 6,and 109(21.2%)had seven or more.Conclusion The production of generics within China′s Essential Medicines List shows significant unevenness,particularly in the excessive replication of evaluated ge⁃nerics in some essential medicines.

关 键 词：国家基本药物目录 仿制药 一致性评价 重复仿制 

分 类 号：R95[医药卫生—药学]