Review of the competitive generic drug incentive system in the United States and its enlightenment to China

GUO Silun; MA Shaoqing

doi:10.6039/j.issn.1001-0408.2023.13.04

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Review of the competitive generic drug incentive system in the United States and its enlightenment to China

更新时间：2025-09-25

- Review of the competitive generic drug incentive system in the United States and its enlightenment to China
- ZHONGGUO YAOFANG Vol. 34, Issue 13, Pages: 1562-1566(2023)
- 作者机构：
  
  北京中医药大学人文学院，北京　102488
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.13.04
  CLC： R951
- Received：14 November 2022，
  
  Revised：2023-03-27，
  
  Accepted：27 March 2023，
  
  Published：15 July 2023
- 稿件说明：
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郭斯伦,马韶青.美国竞争性仿制药激励制度述评及对我国的启示[J].中国药房,2023,34(13):1562-1566.

GUO Silun,MA Shaoqing.Review of the competitive generic drug incentive system in the United States and its enlightenment to China[J].ZHONGGUO YAOFANG,2023,34(13):1562-1566.
郭斯伦,马韶青.美国竞争性仿制药激励制度述评及对我国的启示[J].中国药房,2023,34(13):1562-1566. DOI： 10.6039/j.issn.1001-0408.2023.13.04.

GUO Silun,MA Shaoqing.Review of the competitive generic drug incentive system in the United States and its enlightenment to China[J].ZHONGGUO YAOFANG,2023,34(13):1562-1566. DOI： 10.6039/j.issn.1001-0408.2023.13.04.

摘要

目的

为促进我国仿制药产业和制度发展提供思路和启发。

方法

通过文本分析、实证研究等方式，梳理美国竞争性仿制药激励制度，分析其实施效果和成功经验，为我国相关制度的实施提供参考。

结果

美国竞争性仿制药激励制度通过发布《尚无已批准仿制药的已过专利期及独占期药品清单》，明确鼓励仿制的范围，同时对这些竞争不充分的仿制药采取加快开发和审查、给予市场独占期优待等措施，在激励仿制药申请、加速仿制药上市、促进药价降低方面取得了良好效果，有利于提高药物可及性。

结论

我国借鉴美国竞争性仿制药激励制度符合国内药品供给现状的需要，也具有行业实践基础；可借鉴美国经验，完善我国鼓励仿制药品目录发布制度，优化鼓励仿制药品的审批流程，并给予鼓励仿制药品独占期。

Abstract

OBJECTIVE

To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China.

METHODS

With text analysis， empirical research and other methods， the competitive generic drug incentive system in the United States was combed， its implementation effect and successful experience were analyzed， and the reference was provided for the implementation of relevant systems in China.

RESULTS

The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects： encouraging generic drug applications， accelerating the listing of generic drugs， and promoting drug price reduction， which was ultimately conducive to improving drug accessibility by publishing

List of Off-Patent，Off-Exclusivity Drugs without an Approved Generic

， while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods.

CONCLUSIONS

China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore， we can refer to it， improve the system of releasing the catalog of encouraged generic drugs to be imitated， optimize the approval process for them， and authorize the exclusive period incentive to them.

关键词

Keywords

references

北京知识产权法院课题组 . 中国药品专利链接制度研究 [J/OL ] . 中国审判， 2020 ， 16 ： 94 - 97 [ 2023-03-24 ] . https：//mp.weixin.qq.com/s/nYq4hxBfopCNoKrG8uOMwg https://mp.weixin.qq.com/s/nYq4hxBfopCNoKrG8uOMwg .

FDA . Statement from FDA Commissioner Scott Gottlieb ，M.D.，on new policy to improve access and foster price competition for drugs that face inadequate generic competition[EB/OL ] .（ 2019-02-15 ）[ 2022-11-09 ] . https：//www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-policy-improve-access-and-foster-price-competition https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-policy-improve-access-and-foster-price-competition .

冯霄婵，杨悦 . 美国是如何发展仿制药的：美国药品审评创仿平衡机制研究：上 [N/OL ] . 中国医药报， 2018-08-31 （ 003 ）[ 2022-11-09 ] . http：//bk.cnpharm.com/zgyyb/2018/08/31/93843.html http://bk.cnpharm.com/zgyyb/2018/08/31/93843.html .

FDA . Competitive generic therapies guidance for industry [EB/OL ] .[ 2022-11-09 ] . https：//www.fda.gov/media/136063/download https://www.fda.gov/media/136063/download .

FDA . Competitive generic therapy approvals [EB/OL ] .（ 2022-11-01 ）[ 2022-11-09 ] . https：//www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals .

FDA . FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs [EB/OL ] .（ 2018-08-08 ）[ 2022-11-09 ] . https：//www.fda.gov/news-events/press-announcements/fda-approves-first-generic-drug-under-new-pathway-aimed-enhancing-market-competition-sole-source https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-drug-under-new-pathway-aimed-enhancing-market-competition-sole-source .

FDA . Generic competition and drug prices：new evidence linking greater generic competition and lower generic drug prices [EB/OL ] .（ 2019-12-09 ）[ 2022-12-18 ] . https：//www.fda.gov/media/133509/download https://www.fda.gov/media/133509/download .

FDA . Office of generic drugs 2020 annual report [R/OL ] .（ 2021-02-11 ）[ 2022-12-18 ] . https：//www.fda.gov/drugs/generic-drugs/office-generic-drugs-2020-annual-report https://www.fda.gov/drugs/generic-drugs/office-generic-drugs-2020-annual-report .

FDA . FDA In brief：FDA reaches milestone in competitive generic therapy drug approvals [EB/OL ] .（ 2021-09-02 ）[ 2022-11-09 ] . https：//www.fda.gov/news-events/press-announcements/fda-brief-fda-reaches-milestone-competi- tive-generic-therapy-drug-approvals https://www.fda.gov/news-events/press-announcements/fda-brief-fda-reaches-milestone-competi-tive-generic-therapy-drug-approvals .

毕井泉 . 国务院关于药品管理工作情况的报告 [EB/OL ] .（ 2018-08-08 ）[ 2022-11-09 ] . http：//www.npc.gov.cn/zgrdw/npc/xinwen/2017-06/22/content_2023712.htm http://www.npc.gov.cn/zgrdw/npc/xinwen/2017-06/22/content_2023712.htm .

国家卫生健康委办公厅 . 关于印发第一批鼓励仿制药品目录的通知 [EB/OL ] .（ 2019-10-09 ）[ 2022-11-10 ] . http：//www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=38e3961482c04b59a2aa3e36106b1a4f http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=38e3961482c04b59a2aa3e36106b1a4f .

国家卫生健康委办公厅 . 关于印发第二批鼓励仿制药品目录的通知 [EB/OL ] .（ 2021-03-15 ）[ 2022-11-10 ] . http：//www.nhc.gov.cn/yaozs/s7656/202103/78ab1ead0b51420a-85024ea01a45354c.shtml http://www.nhc.gov.cn/yaozs/s7656/202103/78ab1ead0b51420a-85024ea01a45354c.shtml .

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