Grabowski Henry
Department of Economics, CB 90097, Duke University, Durham, North Carolina 27708, USA.
Nat Rev Drug Discov. 2008 Jun;7(6):479-88. doi: 10.1038/nrd2532. Epub 2008 May 12.
Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. A critical issue in this respect is the period of data exclusivity for innovator companies before a follow-on competitor can rely in part on data obtained for an original biologic for an abbreviated approval. Given the nature of patents on biologics, the period of data exclusivity is anticipated to have a key role in determining how quickly follow-on competitors emerge, and consequently also on the time available for originator companies to recoup their investment. With this issue in mind, this article discusses factors influencing return on investment on biologic research and development. A break-even analysis for a representative portfolio of biologics provides support for a substantial data exclusivity period.
美国国会目前正在考虑制定相关立法，为后续生物制品建立监管途径。在这方面，一个关键问题是创新公司在后续竞争对手能够部分依赖为原研生物制品获取的数据进行简化审批之前的数据独占期。鉴于生物制品专利的性质，预计数据独占期在决定后续竞争对手出现的速度方面将发挥关键作用，因此也会影响原研公司收回投资的时间。考虑到这个问题，本文讨论了影响生物制品研发投资回报的因素。对一组具有代表性的生物制品进行的收支平衡分析为较长的数据独占期提供了支持。
