Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts 02111, USA.
Nat Rev Drug Discov. 2011 Jan;10(1):23-7. doi: 10.1038/nrd3296. Epub 2010 Dec 10.
The development of 'follow on' or 'me too' drugs - generally defined as a drug with a similar chemical structure or the same mechanism of action as a drug that is already marketed - has attracted contrasting views. Some have argued that follow-on drugs often provide useful alternative or enhanced therapeutic options for particular patients or patient subpopulations, as well as introducing price competition. Others, however, consider that the development of such drugs is duplicative and that the resources needed would be better directed elsewhere. Implicit in some of this criticism is the notion that the development of me-too drugs is undertaken after a first-in-class drug has made it to market and proved commercially successful. In this Perspective, using analysis of development and patent filing histories of entrants to new drug classes in the past five decades, we provide new evidence that the development of multiple new drugs in a given class is better characterized as a race, rather than the imitation of successful products.
“跟进”或“me too”药物（通常定义为具有与已上市药物相似的化学结构或相同作用机制的药物）的开发引起了不同的看法。一些人认为，跟进药物通常为特定患者或患者亚群提供了有用的替代或增强的治疗选择，并引入了价格竞争。然而，其他人则认为此类药物的开发是重复的，所需的资源最好用于其他地方。这种批评中隐含的一个观点是，在首创药物进入市场并取得商业成功后，才会开发出类似的 me-too 药物。在本观点中，我们利用过去五十年中进入新药类别的进入者的开发和专利申请历史的分析，提供了新的证据，表明给定类别中多种新药的开发更好地被描述为一场竞赛，而不是对成功产品的模仿。
