治疗等效性评价代码介绍及其对我国仿制药参比制剂选择的影响

doi:10.5246/jcps.2022.08.054

中国药学(英文版) ›› 2022, Vol. 31 ›› Issue (8): 646-651.DOI: 10.5246/jcps.2022.08.054

治疗等效性评价代码介绍及其对我国仿制药参比制剂选择的影响

杨东升, 魏宁漪, 牛剑钊^*(), 许鸣镝^*()

中国食品药品检定研究院, 北京 100050

收稿日期:2022-02-09 修回日期:2022-04-26 接受日期:2022-05-11 出版日期:2022-09-03 发布日期:2022-09-03
通讯作者: 牛剑钊, 许鸣镝
作者简介:
+ Tel.: +86-13661166881, E-mail: xumd@nifdc.org.cn
+ Tel.: +86-13910392600, E-mail: njz@nifdc.org.cn
基金资助:
Carry out quality evaluation research of generic medicinal product control based on domestic product, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China.

The introduction of therapeutic equivalence evaluation codes and its influence on the selection of the reference listed drugs in China

Dongsheng Yang, Ningyi Wei, Jianzhao Niu^*(), Mingdi Xu^*()

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

Received:2022-02-09 Revised:2022-04-26 Accepted:2022-05-11 Online:2022-09-03 Published:2022-09-03
Contact: Jianzhao Niu, Mingdi Xu

摘要/Abstract

摘要：

已批准的具有治疗性等效性评价的药品目录(俗称橙皮书)包括了美国食品药品管理局批准上市的产品, 它是我国化学仿制药选择合适的参比制剂(RLD)的一个非常重要的来源。橙皮书中的多源性处方药会被分配相应的治疗等效性(TE)评价代码, 作为临床药品选择的公共信息。本文以托吡酯缓释胶囊为例, 介绍了TE评价代码系统及其对我国RLD选择的影响。研究结果表明, 我们在选择一个RLD时, 应事先确定其在橙皮书中的TE评价代码, 并选择TE评价代码首字母为A的合适的RLD进行仿制药的研发, 从而提高临床生物等效性试验的成功概率, 降低仿制药开发的风险。

关键词: 参比制剂, 治疗等效性评价代码, 仿制药, 橙皮书

Abstract:

The Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) includes the products approved by Food and Drug Administration (FDA) to be marketed in the USA, and it is an essential source for the selection of suitable reference listed drugs (RLD) for a chemical generic medicinal product. The Orange Book assigns a therapeutic equivalence (TE) evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection. In the present study, we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example. As a result, it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product, which can improve the probability of success of clinical bioequivalence (BE) test and reduce the risk of generic medicinal product development.

Key words: Reference listed drug, Therapeutic equivalence evaluations code, Generic medicinal product, Orange Book

Supporting:

杨东升, 魏宁漪, 牛剑钊, 许鸣镝. 治疗等效性评价代码介绍及其对我国仿制药参比制剂选择的影响[J]. 中国药学(英文版), 2022, 31(8): 646-651.

Dongsheng Yang, Ningyi Wei, Jianzhao Niu, Mingdi Xu. The introduction of therapeutic equivalence evaluation codes and its influence on the selection of the reference listed drugs in China[J]. Journal of Chinese Pharmaceutical Sciences, 2022, 31(8): 646-651.

图/表 3

参考文献 9

[1]	National Medical Products Administration. Announcement on the release for selection and determination procedures of reference listed drug for chemical generic medicinal product (No. 25 in 2019) [EB/OL]. [2019-03-25]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190328162401710.html
[2]	Center for Drug Evaluation, NMPA. Notice on matters related to the reference listed drug for chemical generic medicinal product under evaluation [EB/OL]. [2019-08-15]. https://www.cde.org.cn/main/news/viewInfoCommon/3c0708729d17de019797b3c4bda374f3
[3]	US FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book, 42nd Edition) [EB/OL]. [2022-01-01]. https://www.fda.gov/media/71474/download
[4]	US FDA. Questions and Answers Regarding Methylphenidate Hydrochloride Extended Release Tablets (generic Concerta) made by Mallinckrodt and UCB/Kremers Urban (formerly Kudco) [EB/OL]. [2016-11-04]. https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-regarding-methylphenidate-hydrochloride-extended-release-tablets-generic
[5]	National Medical Products Administration. NMPA's announcement on the release of 51st batch of catalogue of reference listed drug for chemical generic medicinal product (No. 9 in 2022) [EB/OL]. [2022-02-10]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220211161915142.html
[6]	US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations [EB/OL]. [2022-02-16]. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
[7]	National Medical Products Administration. NMPA’s announcement on the release of 29th batch of catalogue of reference listed drug for chemical generic medicinal product (No. 40 in 2020) [EB/OL]. [2020-06-13]. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20200616174201647.html
[8]	National Medical Products Administration. NMPA’s announcement on the release of 31st batch of catalogue of reference listed drug for chemical generic medicinal product (No. 75 in 2020) [EB/OL]. [2020-11-18]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201123164948120.html
[9]	US FDA. Orange Book Preface [EB/OL]. [2022-01-19] https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface

治疗等效性评价代码介绍及其对我国仿制药参比制剂选择的影响

The introduction of therapeutic equivalence evaluation codes and its influence on the selection of the reference listed drugs in China

RichHTML

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

图/表 3

参考文献 9

相关文章 7

编辑推荐

Metrics

本文评价

[1]	刘文夏, 马俊, 杨照, 江滨. 中国仿制药替代影响因素分析——基于"4 + 7"带量采购精神科用药患者角度[J]. 中国药学(英文版), 2023, 32(4): 317-321.
[2]	谢英, 战寒秋, 朱晓虹, 李源, 田如意, 张静, 陈姗姗, 赵艳玲. 恩替卡韦仿制药与原研药治疗慢性乙型肝炎的疗效及依从性的多中心队列研究[J]. 中国药学(英文版), 2021, 30(12): 986-993.
[3]	聂玉瑶, 王贺, 周林光, 史录文, 江滨. 中国药师对仿制药认知的调查研究[J]. 中国药学(英文版), 2020, 29(5): 364-368.
[4]	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.
[5]	杨东升, 马玲云, 牛剑钊, 许鸣镝. 美国国家药品编码应用简介[J]. 中国药学(英文版), 2019, 28(3): 203-208.
[6]	严妍, 李玲, 李蕊, 于文君, 韩毅, 马玉奎, 李妍. 二甲双胍原研制剂格华止?与一种仿制制剂在大鼠模型中药代动力学和药效学比较[J]. 中国药学(英文版), 2019, 28(2): 134-142.
[7]	牛剑钊, 杨东升, 许鸣镝. 欧盟仿制药参比制剂检索与确认简介[J]. 中国药学(英文版), 2018, 27(11): 805-812.