美国生物类似药的注册审批政策（英文）

发布时间：2018-07-24 16:04

【摘要】：生物类似药是继原研生物制品之后进入市场,在安全性、纯度和效价上与原研生物制品具有高度相似性的新药物。欧洲药品管理局(EMA)在生物类似物制品注册审批政策的制定中发挥了引领作用,与此同时世界卫生组织(WHO)为促进全球的协调一致也发布了生物类似药审评指导原则。最近,美国食品药品管理局(FDA)依据美国国会2009年通过的"生物制品价格竞争与创新(Biologics Price Competition and Innovation,BPCI)法案"也被授权审批生物类似药。BPCI法案随后于2010年3月23日生效。为了听取民众对于生物类似药注册审批政策的意见,FDA于2010年11月2—3日举行了一场公众听证会。随后,FDA为了生物类似药的审批,成立了生物类似药审查委员会(BRC)专门负责生物类似药开发相关的科学问题,以及注册审批相关指南的制定。FDA于2012年2月9日颁布了3项生物类似药的指导原则草案(科学目的、关键质量指标、以及问题与解答),这些草案的颁布有2个目的:(1)首先,帮助开发商证明仿制生物类似药的生物相似性,并依据公共健康服务(PHS)法案第351(k)款提交上市申请;(2)其次,充分表达FDA在生物类似药开发与注册审批指导原则制定方面的立场。
[Abstract]:Biological similar drugs are new drugs that have entered the market after original research, and are highly similar to original biological products in safety, purity and titer. The European Drug Administration (EMA) has played a leading role in the formulation of the registration and approval policy for biological analogues, while the WHO (WHO) is to promote the world. The United States Food and Drug Administration (FDA) has recently been authorized to approve biological similar drug.BPCI act in March 23, 2010, based on the "Biologics Price Competition and Innovation (BPCI) Act" approved by the United States Congress in 2009. In order to listen to public opinion on the registration and approval policy of biological similar drugs, FDA held a public hearing on 2 - 3 November 2010. Then, FDA established a biological similar drug review committee (BRC) for scientific issues related to the development of biological similar drugs, as well as the registration and approval guidelines for the approval of biological similar drugs. The draft guidelines for 3 Biological similar drugs (scientific purposes, key quality indicators, and questions and answers) were enacted by.FDA in February 9, 2012. The draft has 2 purposes: (1) first, to help developers to prove the biological similarity of similar drugs, and to submit them on the basis of the public health service (PHS) act 351st (k). City application; (2) Secondly, fully express the position of FDA in the formulation of the guidelines for the development and registration of biological analogues.
【作者单位】： Peking
【分类号】：R95

【共引文献】