美新生物仿制药法案的最新解读

The Latest Interpretation of U.S. Biosimilar Bill

目的: 解读2010年3月23日美国总统奥巴马签署的新医疗改革法案"Patient Protection and Affordable Care Act"中关于生物仿制药的条款及其对生物仿制药行业的影响。方法:检索和综述相关文献。结果和结论: 该法案在美国历史上第一次为生物仿制药建立的快速批准上市途径。对生物制药公司影响深远。

Objective： Reading terms on biosimilars and its impact on generic drugs industry of healthcare reform legislation ＂Patient Protection and Afibrdable Care Act＂ , which was signed into law on March 23, 2010, by President Obama. Methods： To retrieve and review the literature related to the law. Results and Conclusion： The legislation contains provisions that will establish, for the first time, an abbreviated regulatory approval pathway for generic versions of biological medicines （i.e., biosimilars） in the United States. This is the first reports analyzing the impact of this important new law on the biopharmaceutical industry.