The changing landscape of biosimilars in rheumatology.
The changing landscape of biosimilars in rheumatology.
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DOI：
10.1136/annrheumdis-2016-209166
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发表时间：
2016-06
影响因子：
27.4
通讯作者：
Burmester GR
中科院分区：
文献类型：
--
作者：
Dörner T;Strand V;Cornes P;Gonçalves J;Gulácsi L;Kay J;Kvien TK;Smolen J;Tanaka Y;Burmester GR
生物仿制药仍然是风湿病学的热门话题，一些医生对它们在真实的世界中的应用持谨慎态度。随着许多产品进入市场，以及关于其使用的大量指南和建议，有必要了解不断变化的情况以及这些药物提供的真实的临床和健康经济潜力。值得注意的是，风湿病学家将处于生物类似单克隆抗体/可溶性受体使用的最前沿。生物仿制药为我们的患者节省了成本和健康收益，并将在治疗风湿性疾病方面发挥重要作用。我们希望，这些较低的费用将弥补因各国经济差异而造成的治疗机会不平等。由于已批准的生物类似药已证明具有高度相似的疗效，因此最重要的是在各国建立足以监测上市批准后长期安全性的药物警戒数据库。
Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.