摘要
随着生物科技的发展,生物药物在全球医药市场中所占比例正在逐渐提高,近年来会有大批原研药的专利保护期即将结束,这会给生物类似物市场带来新的机遇。据预测,在未来十年间,全球生物类似物市场将增长90倍。为了应对生物类似物市场的快速发展,各国和组织相继出台了相关的指导原则和监管措施。目前,世界范围内已有几十个国家或组织制定了生物类似药相关指南,我国也在2015年发行了《生物类似物研发与评价技术指导原则》(试行)版本。本文将对国内外生物类似物的审批和监管指南进行对比分析,使企业和药品从业人员更深入地了解相关指南,进而促进生物健康产业的发展。
With the development of biotechnology,the proportion of biological drugs in the global pharmaceutical market is gradually increased.In recent years,there will be a large number of the original drug patents out of protection,which will bring new opportunities for biosimilar market.It is predicted that in the next ten years,global biosimilar market will grow90times.To cope with the rapid development of biosimilar market,countries and organizations have issued the relevant guidelines and regulations.At present,there are dozens of countries around the world having made biosimilar related guidelines.In2015,China also issued“Guidelines on Development of Evaluation of Biosimilars(drafting)”.This article will make a comparative analysis on biosimilar approval and regulatory guidelines of domestic and foreign countries,which can also help pharmaceutical workers or pharmacists to understand drug related guidelines in detail,and promote the development of biological health industry.
作者
田月
赵志刚
TIAN Yue;ZHAO Zhi-gang(Department of Pharmacy, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing 100050, China)
出处
《药品评价》
CAS
2017年第4期8-11,38,共5页
Drug Evaluation
基金
"抗多药耐药菌纳米载体的设计及其抗菌性能研究"
北京市自然科学基金资助项目
编号:7164256
关键词
生物药物
生物类似物
审批
监管
指南
Biological Drugs
Biosimilars
the Examination and Approval
Regulatory
Guideline
