【摘要】 本文回顾了自《1984年药品价格竞争与专利期补偿法案》实施、创立美国仿制药行业以来,美国仿制药行业的发展经验和教训。对仿制药丑闻、仿制药审批制度发展、生物等效性与可替代性、复杂剂型的生物等效性方法、专利常青、授权仿制药、仿制药安全性、仿制药审评、仿制药替代、4美元仿制药等美国仿制药行业发展中的关键性事件和过程进行了系统回顾与分析。美国仿制药行业在头25年发展历程中的经验教训,对其他希望建立或重新建立国内仿制药行业的国家有借鉴作用。更多还原

【Abstract】 The lessons in the development of the US generic drug industry since the enacting of Drug Price Competition and Patent Term Restoration Act(DPC & PTR Act) that resulted in the creation of the US generic drug industry were summarized.The evolution and key events in the development of the US generic drug industry in the first 25 years,including generic drug scandal,the evolution of approval for generic drugs,bioequivalence and switchability,bioequivalence for complicated dosage forms,patent evergreening,authorized generics,generic drug safety,the issues in generic drug review,the generic drug substitution system,$4 generics,were systemically reviewed and analyzed.The history of the first 25 years of the US Generic Drug Industry has presented several lessons which are of benefit to others wishing to establish or reestablish a domestic generic drug industry.更多还原