刍议美国生物类似药行动计划
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摘要
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比制剂具有相似性的治疗性生物制品。结合美国、欧盟、日本和世界卫生组织对生物类似药研发及监管思路,重点介绍了2018年度美国食品药品监督管理局发布的《生物类似药行动计划——简介和概述:创新与竞争间的平衡》,以期对我国生物类似药监管政策的制定提供借鉴。
A biosimilar product is a biological product based on a showing that it is highly similar to an approved biological product,known as a reference product,and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.In this paper,the US,EU,Japan and the World Health Organization's thoughts on the research,development and supervision of biosimilar are reviewed.And then we focused on the U.S.Food and Drug Administration's Biosimilar Action Plan —Introduction and Overview:Balancing Innovation and Competition,in order to provide references for the formulation of regulatory policies for biosimila in China.
A biosimilar product is a biological product based on a showing that it is highly similar to an approved biological product,known as a reference product,and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.In this paper,the US,EU,Japan and the World Health Organization's thoughts on the research,development and supervision of biosimilar are reviewed.And then we focused on the U.S.Food and Drug Administration's Biosimilar Action Plan —Introduction and Overview:Balancing Innovation and Competition,in order to provide references for the formulation of regulatory policies for biosimila in China.
引文
[1]FDA.Biosimilars Action Plan:Balancing Innovation and Competition[EB/OL].(2018-07-18)[2018-07-20].https://www.fda.gov/ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/ucm613761.pdf.
[2]陈永法,伍琳.欧盟生物类似药注册监管政策实施效果及启示[J].中国新药杂志,2016,15(1):7-12.
[3]范玉明,王雅雯,郑丽娥.国内外生物类似药注册管理概述及启示[J].中国药事,2016,30(4):309-320.
[4]陈永法,卞云云,伍琳.日本生物类似药注册监管政策绩效评价研究及启示[J].中国卫生政策研究,2016,9(12):50-55.
[5]韦薇,白玉,尹红章.WHO"生物类似药"质量研究相关指导原则的解析[J].中国生物制品学杂志,2014,27(6):868-872.
[6]萧惠来.FDA对生物类似药临床药理学生物相似性研究的要求[J].药物评价研究,2017,40(5):586-592.
[7]国家食品药品监督管理总局.生物类似药研发与评价技术指导原则(试行)[EB/OL].(2015-02-28)[2018-08-23].http://www.sda.gov.cn/WS01/CL0087/115103.html.
[8]陈永法,王翠玲,伍琳.美国生物类似药研发与上市制度及对我国的启示[J].中国医药工业杂志,2016,47(10):1333-1338.
[2]陈永法,伍琳.欧盟生物类似药注册监管政策实施效果及启示[J].中国新药杂志,2016,15(1):7-12.
[3]范玉明,王雅雯,郑丽娥.国内外生物类似药注册管理概述及启示[J].中国药事,2016,30(4):309-320.
[4]陈永法,卞云云,伍琳.日本生物类似药注册监管政策绩效评价研究及启示[J].中国卫生政策研究,2016,9(12):50-55.
[5]韦薇,白玉,尹红章.WHO"生物类似药"质量研究相关指导原则的解析[J].中国生物制品学杂志,2014,27(6):868-872.
[6]萧惠来.FDA对生物类似药临床药理学生物相似性研究的要求[J].药物评价研究,2017,40(5):586-592.
[7]国家食品药品监督管理总局.生物类似药研发与评价技术指导原则(试行)[EB/OL].(2015-02-28)[2018-08-23].http://www.sda.gov.cn/WS01/CL0087/115103.html.
[8]陈永法,王翠玲,伍琳.美国生物类似药研发与上市制度及对我国的启示[J].中国医药工业杂志,2016,47(10):1333-1338.