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A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence
Expert Opinion on Biological Therapy ( IF 4.6 ) Pub Date : 2022-02-18 , DOI: 10.1080/14712598.2021.1958778
Fabio Salvatore Macaluso 1 , Jr Fraser Cummings 2 , Raja Atreya 3 , Jaeyun Choi 4 , Ambrogio Orlando 1
Affiliation  

ABSTRACT

Introduction

The infliximab biosimilar SB2 was approved in the EU (2016, Flixabi®) and the US (2017, Renflexis®) for the same indications as the reference product (Remicade®) based on a robust analytical and clinical data package.

Areas covered

This systematic literature review summarizes available analytical and clinical data on SB2, including randomized controlled clinical trials and real-world evidence studies. Overall, 184 articles and congress abstracts were identified (excluding duplicates), whereof 5 reports on analytical data, four reports on two randomized controlled trials and 13 reports of real-world evidence studies were included.

Expert opinion

The available analytical and clinical data support the equivalence of SB2 to the reference product across approved indications. This is further supported by emerging real-world evidence, particularly in extrapolated indications such as inflammatory bowel disease for both infliximab-naïve patients and patients already established on infliximab switching to SB2. Switching from originator or biosimilar infliximab to SB2 including both single and multiple switches was not associated with an increased risk of loss of treatment response or any safety or immunogenicity concerns. Overall, the approved infliximab biosimilar SB2 is safe and effective in clinical practice across licensed indications.



中文翻译:

英夫利昔单抗生物仿制药 SB2 的系统评价:从临床前数据到真实世界证据

摘要

介绍

基于强大的分析和临床数据包,英夫利昔单抗生物仿制药 SB2 在欧盟(2016 年,Flixabi®)和美国(2017 年,Renflexis®)获得了与参考产品(Remicade®)相同的适应症。

涵盖的领域

本系统文献综述总结了 SB2 的可用分析和临床数据,包括随机对照临床试验和真实世界证据研究。总共确定了 184 篇文章和大会摘要(不包括重复),其中包括 5 篇分析数据报告、4 篇关于两项随机对照试验的报告和 13 篇真实世界证据研究报告。

专家意见

现有的分析和临床数据支持 SB2 在批准的适应症中与参考产品的等效性。新出现的现实世界证据进一步支持了这一点,特别是对于英夫利昔单抗初治患者和已经确定英夫利昔单抗转为 SB2 的患者的外推适应症,例如炎症性肠病。从原研药或生物仿制药英夫利昔单抗转换到包括单次和多次转换的 SB2 与治疗反应丧失或任何安全性或免疫原性问题的风险增加无关。总体而言,已获批准的英夫利昔单抗生物仿制药 SB2 在临床实践中的所有许可适应症都是安全有效的。

更新日期:2022-02-18
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