美国竞争性仿制疗法审评路径研究及启示

Research on the Competitive Generic Therapy Pathway in the United States and Its Inspiration

目的分析美国竞争性仿制疗法审评路径,为我国仿制药审评政策提供参考。方法通过制度研究与描述性统计,全面梳理与分析了美国竞争性仿制疗法审评路径的制度内容与实施效果。结果美国竞争性仿制疗法直接与药品市场竞争状态挂钩,通过资格认定,并设置上市前与上市后双向激励措施,制度实施效果较好。截至2022年1月,FDA已批准具有竞争性仿制疗法资格的仿制药167项。结论我国亦面临鼓励“竞争不充分”的仿制药研发的问题,建议从《中国药品上市目录集》、单独的加快审评路径、首仿药市场独占期等方面完善现有政策,有效加快缺乏竞争的仿制药上市进程。

OBJECTIVE To analyze American competitive generic therapy(CGT)pathway and provide a reference for the reform of generic drugs review policy in China.METHODS Through the system studies and descriptive statistics,this paper analyzed the system content and implementation effect of the CGT pathway in the United States.RESULTS The CGT pathway is directly linked to the state of drug market competition.Through setting two-way incentive measures before and after listing,the implementation effect is good.As of January 2022,FDA has approved 167 generic drugs with CGT designation.CONCLUSION China is also facing the problem of encouraging the R&D of generic drugs with“inadequate generic competition”.It is suggested to improve the existing policies from the aspects of catalogue of listed drugs,a separate pathway of expedited review for generic drugs and the first generic drug market exclusivity,so as to effectively accelerate the listing process of generic drugs lacking competition.