生物类似药安全性评价现状  

The current status of safety evaluation of biosimilars

作　　者：孙雪林[1] 钱东方 金鹏飞[1] 张亚同[1] SUN Xuelin;QIAN Dongfang;JIN Pengfei;ZHANG Yatong(Department of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Beijing North Medical Health Economic Research Center,Beijing 100021,China)

机构地区：[1]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,北京100730 [2]北京北方医药健康经济研究中心,北京100021

出　　处：《临床药物治疗杂志》2025年第1期49-54,共6页Clinical Medication Journal

基　　金：中央高水平医院临床科研业务费资助项目(BJ-2023-200)。

摘　　要：生物类似药因其分子结构复杂和生产过程严格而广受关注,其安全性评价成为全球医药界关注的焦点。本文从生物类似药的定义出发,深入探讨不同国家(地区)的安全性评价标准,并分析生物类似药与原研药在安全性上的异同;生物类似药依赖于严格的国际(地区)生产标准,这些标准虽各有不同,但都强调药品的质量、安全性和有效性;剖析生物类似药面临的技术挑战,并提供了可能的解决方案。监管机构应进一步加强生物类似药的安全性评价标准的制定,为未来制定仿制药的安全使用政策提供指引。Biosimilars have attracted widespread attention due to their complex molecular structure and strict production process,and their safety evaluation has become the focus of attention in the global pharmaceutical industry.This paper discusses the safety evaluation standards of biosimilars in different countries(regions)from the definition of biosimilars,and analyzes the similarities and differences in safety between biosimilars and originator drugs.Biosimilars rely on strict international(regional)production standards,which,although different,emphasize the quality,safety and effectiveness of drugs.This article also analyzes the technical challenges faced by biosimilars and provides possible solutions.Regulators should further strengthen the formulation of safety evaluation criteria for biosimilars,to provide guidance for formulating the futurepolicies on the safe use of generic drugs.

关 键 词：生物类似药 安全性评价 监管标准 技术挑战 

分 类 号：R95[医药卫生—药学]