University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Clin Pharmacol Ther. 2010 Feb;87(2):157-9. doi: 10.1038/clpt.2009.249.
As Congress begins drafting legislation concerning the US Food and Drug Administration (FDA) regulation of biosimilars, it is critical to keep in mind that these agents may differ from their innovator compounds. Therefore, it is of the utmost importance to be able to differentiate among innovators and biosimilars in administrative data in order to facilitate the conduct of population-based safety and comparative effectiveness studies. This Commentary proposes methods that would allow these agents to be distinguished in such data.
随着国会开始起草有关美国食品和药物管理局（FDA）监管生物类似药的立法，必须牢记这些药物可能与其创新化合物有所不同。因此，在管理数据中能够区分创新药物和生物类似药至关重要，以便于进行基于人群的安全性和疗效比较研究。本评论提出了可以在这些数据中区分这些药物的方法。
