Research on the Competitive Generic Therapy Pathway in the United States and Its Inspiration
YAO Xue-fang1, YU Zi-jing2, LI peng-hui3
1. Nanjing University of Chinese Medicine, Nanjing 210023, China; 2. Institute of Medical Information, Chinese Academy of Medical Sciences, Beijing 100020, China; 3. Roche (China) Investment Co., Ltd., Beijing 100020, China
Abstract：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.
姚雪芳, 俞子静, 李鹏辉. 美国竞争性仿制疗法审评路径研究及启示[J]. 中国药学杂志, 2022, 57(21): 1860-1864.
YAO Xue-fang, YU Zi-jing, LI peng-hui. Research on the Competitive Generic Therapy Pathway in the United States and Its Inspiration. Chinese Pharmaceutical Journal, 2022, 57(21): 1860-1864.
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2022, Vol. 57 
