炎症性肠病的生物类似药:一般概念和临床意义

Sabrina Rodrigues de Figueiredo, Ana Elisa Rabe Caon, R. Saad Hossne, F. Vieira Teixeira, Sabine Murakami Winkler, N. Sousa Freitas Queiroz
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引用次数: 2

摘要

随着时间的推移,炎症性肠病(IBD)的治疗方法发生了变化,越来越多地使用生物制剂来实现治疗目标。因此,治疗费用大大增加,因此有必要制定能够增加获得生物疗法的战略。在这种情况下,开发生物仿制药的目的是降低成本,保持与原研药相比的安全性和有效性。最初,它在IBD中的应用是基于其他专业(如风湿病学)研究的外推。最近,在炎症性肠病的研究已经出现,其使用的有利结果。众所周知,在使用生物仿制药方面仍然存在知识空白,需要更多的经验来提高临床医生对其临床实践的信心。本章对目前已知的IBD生物类似药进行了综述。讨论了安全性、有效性、互换性、免疫原性和开关性等方面的问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biosimilars in Inflammatory Bowel Diseases: General Concepts and Clinical Implications
The treatment of inflammatory bowel disease (IBD) has changed over time with the increasing use of biologics to achieve therapeutic goals. As a result, the cost of treatment increased considerably, making it necessary to develop strategies that could increase access to biological therapies. In this scenario, the biosimilars were developed with the aim of reducing costs, maintaining safety and efficacy compared to the originator. Initially, its use in IBD was based on the extrapolation of studies in other specialties, such as rheumatology. More recently, studies in inflammatory bowel disease have emerged, with favorable results for its use. It is known that there are still knowledge gaps in the use of biosimilars and more experience is needed to increase clinicians’ confidence in their clinical practice. This chapter proposes a review of what is currently known about biosimilars in IBD. It discusses about aspects such as safety, efficacy, interchangeability, immunogenicity and switches.
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