Page 127 - 2020年2月第31卷第3期

多维度关注生物类似药的管理与临床应用 Δ

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梅 丹 ，都丽萍，张钰宣（中国医学科学院/北京协和医学院北京协和医院药剂科，北京 100730）

中图分类号 R979.9 文献标志码 A 文章编号 1001-0408（2020）03-0373-06
DOI 10.6039/j.issn.1001-0408.2020.03.24

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。
关键词 生物类似药；药品管理；临床应用

Multi-dimensional Focus on the Management and Clinical Use of Biosimilar Products
MEI Dan，DU Liping，ZHANG Yuxuan（Dept. of Pharmacy，Peking Union Medical College Hospital，Chinese
Academy of Medical Sciences/Peking Union Medical College，Beijing 100730，China）

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.
KEYWORDS Biosimilar products；Drug management；Clinical application

近年来，生物制品在治疗领域显现出临床优势，无
Δ 基金项目：首都卫生发展科研专项（No.2018-3-4017）；中国医学
论国内或国外，生物制品用作治疗性药品已呈飞速增长
科学院医学与健康科技创新工程（No.2017-I2M-1-011）
＊主任药师。研究方向：医院药学、药事管理。电话：010- 的态势。具有临床价值的新的生物药可通过绿色通道
69156533。E-mail：meidanpumch@163.com 或优先审评审批程序研发上市 [1-2] ，上市产品呈爆发式增

中国药房 2020年第31卷第3期 China Pharmacy 2020 Vol. 31 No. 3 ·373 ·