Drug Discovery Today ( IF 7.4 ) Pub Date : 2017-09-01 , DOI: 10.1016/j.drudis.2017.08.008 Melek Simsek , Berrie Meijer , Adriaan A. van Bodegraven , Nanne K.H. de Boer , Chris J.J. Mulder
Identifying new indications for existing drugs creates new therapeutic options while bypassing much of the costs and time involved with bringing a new drug to market. The rediscovery of a generic drug, however, is a challenging pursuit because there is no formal regulatory approach and a lack of economic interest by pharmaceutical companies. This played a part in the re-registration of thioguanine as a rescue drug for the treatment of patients with inflammatory bowel disease in The Netherlands. In this article, we aim to underline the importance of drug rediscovery, the difficulties of this procedure in Europe and we attempt to suggest conceivable solutions.
中文翻译:
在旧药中发现隐藏的宝藏:仿制药许可的挑战和重要性
确定现有药物的新适应症会创造新的治疗选择,同时避免将新药推向市场所需的大量成本和时间。然而,重新发现仿制药是一项具有挑战性的追求,因为没有正式的监管方法,而且制药公司缺乏经济利益。这在荷兰重新注册了硫鸟嘌呤作为抢救药物治疗炎症性肠病患者的一部分。在本文中,我们旨在强调药物重新发现的重要性,该程序在欧洲的困难,并尝试提出可行的解决方案。