Gaviria Alejandro, González Claudia Patricia Vaca, Muñoz Carolina Gómez, Morales Álvaro Andrés
Rev Panam Salud Publica. 2016 Aug;40(1):40-47.
In September 2014, Colombia issued standards for the evaluation of biological drugs within the framework of the marketing authorization process. The Colombian approach explicitly includes a fast track for evaluating competing biologicals, which caused great national and international controversy. This article explains the context that justifies the need for this fast-track approach, critically analyzes comparability as a paradigm for the evaluation of biogenerics, and shows that Colombia's position is not isolated and is based on global regulatory trends.
2014年9月，哥伦比亚在药品上市许可程序框架内发布了生物药评估标准。哥伦比亚的做法明确包括了评估竞争性生物药的快速通道，这在国内和国际上都引起了极大争议。本文解释了这种快速通道方法必要性的背景，批判性地分析了可比性作为生物类似药评估范式的情况，并表明哥伦比亚的立场并非孤立，而是基于全球监管趋势。
