多维度关注生物类似药的管理与临床应用
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篇名: 多维度关注生物类似药的管理与临床应用
TITLE: Multi-dimensional Focus on the Management and Clinical Use of Biosimilar Products
摘要: 目的:为提高生物类似药的管理与临床应用水平提供参考。方法:检索国内外药品监管部门和世界卫生组织有关生物类似药审批和应用管理相关的政策法规,从药品全生命周期、通用名和处方、适应证外推、临床用药互换、药物警戒、医保支付体系、教育培训等多维度对生物类似药进行梳理。结果与结论:生物类似药是指在质量、安全性和有效性方面与已获准上市的参照药具有相似性的治疗性生物制品。在生物类似药的研发、生产、流通、使用、监管全生命周期系列环节中的管理在不同国家/地区/组织各有特点,其在研发阶段不需再独立验证安全性和有效性,只需用分析方法逐步从结构和功能上阐明其与参照药高度相似性即可;我国的生物类似药命名与原研药相同,采用通用名处方;美国FDA批准生物类似药的适应证外推需要基于其申请时的数据和信息、参照药的安全性和有效性信息及适应证相关科学要素的考量,需要经过评估,在监管下有条件地使用;美国FDA审批可替换生物类似物的标准严格,即实现互换的审批标准要高于生物相似的审批标准,但我国目前尚无这一概念;医药企业、监管机构、学术机构、医院药房之间需沟通交流,共同加强上市后风险控制和安全性监测;我国医疗保障部门需建立适宜的支付体系并通过支付制度鼓励生物类似药的使用;医务工作者要学习生物类似药的特点,才能在了解其技术审评的基础上,于实践中用好生物类似药。
ABSTRACT: OBJECTIVE:To provide reference for summarize the management and clinical use levels of biosimilar products . METHODS:Related policies and regulations about approval and application of biosimilar products were retrieved from domestic and foreign supervision departments and WHO. The biosimilar products were described from multi-dimensional aspects of whole life cycle of drugs ,generic name and prescription ,indication extrapolation ,clinical drug exchange ,pharmacovigilance,medical insurance payment system ,education and training. RESULTS & CONCLUSIONS :Biosimilar products refer to therapeutic biological products which are similar to the reference drugs which have been approved for marketing in terms of quality ,safety and effectiveness. In R&D ,production,circulation,use and supervision links,the management of biosimilar products has its own characteristics in different countries/areas/organization. In the R&D stage ,biosimilar products do not need to independently verify their safety and effectiveness ,but only step by step use analytical methods to gradually clarify their high similarity with reference drugs in terms of structure and function. The name of biosimilar products in China is the same as that of the original drugs ,and the general name was used in prescription. For FDA to approve the indication extrapolation of biosimilar products ,it needs to be based on the data and information at the time of application ,the safety and effectiveness information of reference drugs ,and the consideration of relevant scientific elements of indications. It needs to be evaluated and used conditionally under supervision. The standard of FDA approval is strict,that is to say ,the approval standard of realizing interchangeability is higher than that of biological similarity which has no such concept in China. The enterprise community ,regulatory agencies ,academic institutions and hospital drug rooms need to communicate and exchange ,and further strengthen post market risk control and safety monitoring. China’s medical insurance department should establish an appropriate payment system and encourage the use of biosimilar products through the payment system. Meclical workers should learn the characteristics of biosimilar products so that they can make good use of biosimilar products in practice on the basis of understanding their technical evaluation.
期刊: 2020年第31卷第03期
作者: 梅丹,都丽萍,张钰宣
AUTHORS: MEI Dan,DU Liping ,ZHANG Yuxuan
关键字: 生物类似药;药品管理;临床应用
KEYWORDS: Biosimilar products ;Drug management ;Clinical application
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