中国新药杂志

生物类似药临床用药互换的思考与建议

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徐子悦 ¹ , 韩晟 ² , 管晓东 ¹^,² , 史录文 ¹^,²

中国新药杂志 | 新药述评与论坛 2021,30(17): 1554-1558

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中国新药杂志 |新药述评与论坛 2021 , 30 (17) : 1554 -1558

生物类似药临床用药互换的思考与建议

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徐子悦¹, 韩晟², 管晓东¹^,², 史录文¹^,²

作者信息

¹北京大学药学院，北京　100191

²北京大学医药管理国际研究中心，北京　100191

通讯作者:

史录文，男，教授，博士生导师，主要从事宏观药物政策、药品价格政策和药物经济学研究。联系电话：（010）82805019, E-mail：shilu@bjmu.edu.cn。

作者简介:

徐子悦，女，硕士研究生，主要从事药物政策研究。E-mail：xuziyue96@163.com。

Consideration and suggestion on clinical drug switching of biosimilars in China

Zi-yue XU¹, Sheng HAN², Xiao-dong GUAN¹^,², Lu-wen SHI¹^,²

Affiliations

¹School of Pharmaceutical Sciences, Peking University, Beijing 100191, China

²International Research Center for Medicinal Administration, Peking University, Beijing 100191, China

出版时间: 2021-09-15

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摘要

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本文旨在为中国生物类似药上市后临床用药互换监管政策与实践提出建议。查阅文献和相关政策，简述中国生物类似药发展现状，梳理欧美生物类似药可互换性监管经验和临床用药互换研究进展。中国生物类似药发展迅速，但相关制度建设仍需完善。欧美国家已初步建立生物类似药临床用药互换监管制度，但目前实践经验和研究证据有限，专家共识尚未建立。生物类似药与原研生物药在临床可互换性上仍存在争议，监管机构需重视生物类似药临床用药互换安全性问题，应建立并完善临床数据公开、可互换性评价、药品命名溯源、互换激励制度等相关政策。

关键词

生物类似药 / 原研生物药 / 临床用药互换 / 可互换性

Abstract

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The aim of this article is to make some suggestions for the regulations on interchangeability and clinical drug switching of biosimilar in China. Literature and relevant policies were reviewed. The development status of biosimilars in China was summarized, the regulatory experiences on the interchangeability of biosimilars in the United State and European Union were combed, and research findings on clinical drug switching were analyzed as well. Biosimilars have developed rapidly in China, but the related regulatory system has not been completely established. The United States and European Union have already initially established the management of biosimilar interchangeability, while the practical experience and clinical evidence are limited, and expert consensus has not been reached. There are still potential risks and concerns on switching from an originator biologic to a biosimilar or from one biosimilar to another. Drug regulatory authority should pay more attention to drug safety, clinical data information transparency, and technical guidelines on interchangeability, drug traceability, and incentive system.

Key words

biosimilar / reference product / clinical drug switching / interchangeability

引用本文

徐子悦, 韩晟, 管晓东, 史录文. 生物类似药临床用药互换的思考与建议. 中国新药杂志, 2021 , 30 (17) : 1554 -1558 .

Zi-yue XU, Sheng HAN, Xiao-dong GUAN, Lu-wen SHI. Consideration and suggestion on clinical drug switching of biosimilars in China[J]. Chinese Journal of New Drugs, 2021 , 30 (17) : 1554 -1558 .

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2021年第30卷第17期

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首发时间：2026-10-28
出版时间：2021-09-15

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录用日期：2021-02-01

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作者信息

¹北京大学药学院，北京　100191

²北京大学医药管理国际研究中心，北京　100191

通讯作者:

史录文，男，教授，博士生导师，主要从事宏观药物政策、药品价格政策和药物经济学研究。联系电话：（010）82805019, E-mail：shilu@bjmu.edu.cn。

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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