美国授权仿制药应用简介

doi:10.5246/jcps.2019.06.043

中国药学(英文版) ›› 2019, Vol. 28 ›› Issue (6): 439-445.DOI: 10.5246/jcps.2019.06.043

• 【药事管理与临床药学专栏】 • 上一篇下一篇

美国授权仿制药应用简介

杨东升, 马玲云, 牛剑钊, 许鸣镝^*

中国食品药品检定研究院, 北京 100050

收稿日期:2019-03-25 修回日期:2019-04-16 出版日期:2019-06-30 发布日期:2019-04-29
通讯作者: Tel.: +86-13521033996, E-mail: yangdongsheng@nifdc.org.cn
基金资助:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

Brief introduction for application of USA authorized generic drugs

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu^*

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2019-03-25 Revised:2019-04-16 Online:2019-06-30 Published:2019-04-29
Contact: Tel.: +86-13521033996, E-mail: yangdongsheng@nifdc.org.cn
Supported by:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

摘要/Abstract

摘要：

授权仿制药是指经已批准上市品牌药(通常指创新药)的发起人或持有人许可而在美国市场销售的药品, 除标签上不能有品牌名外, 其与相应的品牌药在其他方面是基本相同的。在我国仿制药质量和疗效的一致性评价过程中, 对于已经发布的仿制药参比制剂, 其市场可及性是能否顺利开展一致性评价研究的首要问题。本文系统介绍了美国授权仿制药的定义, 相关背景, 以及其与仿制药的区别。同时, 以我国仿制药参比制剂目录(第一批)收录的源于美国橙皮书的参比制剂为例, 结合授权仿制药目录, 美国橙皮书以及国家药品编码目录, 介绍了授权仿制药的查询方法。当仿制药参比制剂的可及性出现问题时, 可以为制药企业查找, 辨别和购买相应的授权仿制药提供参考。

关键词: 授权仿制药, 新药申请, 国家药品编码, 参比制剂, 仿制药质量与疗效一致性评价, 橙皮书

Abstract:

The authorized generic drugs (AGs) are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug (usually refers to an innovator drug). Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the brand name product. In China, for those published comparator products of generic drug products, the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs. In the present paper, we systemically elaborated the definition, classification and relevant background of the AGs, as well as their differences to the generic drugs. At the same time, by taking drug products, which are adopted in the Chinese comparator product directories for generic medicinal products (first batch) and sourced from USA orange book, as examples, we introduced the searching process of the AGs with the integration of FDA listing of AGs, the USA orange book and the USA national drug code directory. It can facilitate the domestic and foreign pharmaceutical enterprises to search, identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.

Key words: Authorized generic drugs, New drug application, National drug code, Comparator product, Re-evaluation of generic medicinal product, Orange book

中图分类号:

R951

Supporting:

杨东升, 马玲云, 牛剑钊, 许鸣镝. 美国授权仿制药应用简介[J]. 中国药学(英文版), 2019, 28(6): 439-445.

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu. Brief introduction for application of USA authorized generic drugs[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(6): 439-445.

参考文献

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[2] China Food and Drug Administration. Related Matters concerned to the Published Comparator Product [EB/OL]. [2017-08-18]. http://samr.cfda.gov.cn/WS01/CL1751/ 176236.html.

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[8] US FDA. FDA Listing of Authorized Generics [EB/OL]. [2019-03-28]. https://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm126391.htm.

[9] US FDA. Generic Drugs [EB/OL]. [2018-06-05]. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/default.htm.

[10] US FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book, 38th Edition) [EB/OL]. [2018-01-01] https://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/UCM071436.pdf.

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[12] Center for Drug Evaluation of National Medical Products Administration. Publicity on the release of 21 st batch of Chinese Comparator Product directories for generic medicinal product [EB/OL]. [2019-03-28]. http://www.cde.org.cn/news.do?method=viewInfo Common&id=314837.

[13] China Food and Drug Administration.CFDA’s announcement on the release of first batch of Chinese Comparator Product directories for generic medicinal product (No. 45 in 2017) [EB/OL]. [2017-03-17]. http://www.sda.gov.cn/WS01/CL1757/170862.html.

[14] US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations [EB/OL]. [2019-03]. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.

[15] Yang, D.S.; Ma, L.Y.; Niu, J.Z.; Xu, M.D. Brief introduction for application of the USA national drug code. J. Chin. Pharm. Sci. 2019, 28, 203-208.

美国授权仿制药应用简介

Brief introduction for application of USA authorized generic drugs

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