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Review Article

我们能从一种免疫介导的炎症性疾病推断出另一种炎症性疾病的数据吗？

卷 26, 期 2, 2019

页: [248 - 258] 页: 11

弟呕挨: 10.2174/0929867325666181101114937

价格: $65

摘要

免疫介导的炎症性疾病有几种致病途径，这有时推动从一种疾病或指征推断到另一种疾病或指征。生物仿制药可定义为生物治疗产品，其质量、安全性和功效与已获得许可的主要生物治疗产品相似。我们回顾了用于外推的底物、当前生物仿制药的批准程序以及对类风湿关节炎患者进行生物仿制药的开创性研究。生物仿制药与其创新产品具有相同的氨基酸序列。然而，翻译后的修改可能发生，目前的分析技术不允许最终结构。为了检验一种适应症的疗效，应选择相同的人群，免疫原性特征对于转换和互换性至关重要。CT-P13（remsima™；inflectra™）是一种生物仿制药（remicader）。它满足大多数外推的要求。然而，在炎症性肠病（IBD）中，我们需要更多的研究来证实从类风湿性关节炎和强直性脊柱炎到IBD的推断假设。此外，有效的药物警戒计划是强制性的，以寻找免疫原性和副作用。

关键词: 生物仿制药，炎症性肠病，克罗恩病，溃疡性结肠炎，生物制剂，英夫利昔单抗。

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