期刊
CURRENT RHEUMATOLOGY REPORTS
卷 19, 期 6, 页码 -出版社
SPRINGER
DOI: 10.1007/s11926-017-0658-4
关键词
Biologics; Biosimilars; Switching; Clinical trials; Real world data
类别
资金
- Pfizer
Purpose of Review Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference -> biosimilar switching are limited. This review was carried out to assess the current body of switching data. Recent Findings Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2). Etanercept publications covered SB4 (2) and GP2015 (2). Adalimumab publications covered ABP 501 (2) and SB5 (1). Rituximab publications covered CT-P10 (1). Efficacy and safety data generally showed no differences between patients who switched treatments versus those who did not. No differences were seen pre- and post-switch. Immunogenicity data were presented in 19/37 (51%) studies. Summary Additional data from switching studies of these therapies are still required, as is continuing pharmacovigilance. Switching should remain a case-by-case clinical decision made by the physician and patient on an individual basis supported by scientific evidence.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据