Office of Planning, Food and Drug Administration, Silver Spring, MD, USA.
Health Aff (Millwood). 2013 Aug;32(8):1433-9. doi: 10.1377/hlthaff.2012.0541.
For more than a decade, industry analysts and policy makers have raised concerns about declining pharmaceutical innovation, citing declining numbers of new molecular entities (NMEs) approved in the United States each year. Yet there is little consensus on whether this is the best measure of "innovation." We examined NME approvals during 1987-2011 and propose the three distinct subcategories of NMEs--first-in-class, advance-in-class, and addition-to-class--to provide more nuanced and informative insights into underlying trends. We found that trends in NME approvals were largely driven by addition-to-class, or "me too," drug approvals, while first-in-class approvals remained fairly steady over the study period. Moreover, the higher proportion of first-in-class drug approvals over the most recent decade is an encouraging sign of the health of the industry as a whole.
十多年来，行业分析师和政策制定者一直对药品创新的下降表示担忧，他们指出美国每年批准的新分子实体（NME）数量不断减少。然而，对于这是否是衡量“创新”的最佳标准，人们的看法并不一致。我们考察了 1987 年至 2011 年期间 NME 的批准情况，并提出了 NME 的三个不同亚类——first-in-class（同类首创）、advance-in-class（同类进步）和 addition-to-class（同类加新），以更细致和更有信息量的方式深入了解潜在趋势。我们发现，NME 批准趋势在很大程度上是由 addition-to-class（“me too”）药物批准驱动的，而同类首创药物的批准在研究期间基本保持稳定。此外，最近十年同类首创药物批准比例的提高，是整个行业健康状况的一个令人鼓舞的迹象。
