【摘要】 介绍美国授权仿制药的监管体系,分析我国和美国存在的差异,探讨其对我国可能产生的影响,并推动相关研究。授权仿制药作为一种特殊的仿制药,在美国是原研药制药企业抢占市场份额的重要工具。对我国来说,将来可能对我国仿制药市场竞争产生不利影响,降低制药企业的积极性;但另一方面在特殊时期可作为解决突发公共卫生问题的手段,还可促使我国制药企业主动转型升级。销售授权仿制药是主流市场的通用策略,有利有弊,我国制药企业需要提高自身竞争力,做好应对策略。更多还原

【Abstract】 This paper introduces the regulatory system of authorized generic drugs in the United States(US),analyzes the differences between China and the US,and discusses its possible impact on China, to promote relevant researches. Authorized generics, as a special type of generics, is an important tool for the original drug enterprises to occupy the market share in the US. For our country, it may be harmful to the generic competition, and reduce the enthusiasm of pharmaceutical enterprises. In the contrast, it can be used to solve public health emergencies at special periods, and to force the pharmaceutical enterprises to take the initiative to transform and upgrade. Sale of authorized generics is a common strategy in the mainstream market. Everything has its two sides, the pharmaceutical enterprises of our country need to improve our competitiveness, and be ready to cope with the competition.更多还原