Dörner Thomas, Strand Vibeke, Cornes Paul, Gonçalves João, Gulácsi László, Kay Jonathan, Kvien Tore K, Smolen Josef, Tanaka Yoshiya, Burmester Gerd R
Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin, Berlin, Germany Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany.
Division Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
Ann Rheum Dis. 2016 Jun;75(6):974-82. doi: 10.1136/annrheumdis-2016-209166. Epub 2016 Mar 8.
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.
生物类似药仍是风湿病领域的热门话题,一些医生对其在现实世界中的应用持谨慎态度。随着众多产品上市以及大量关于其使用的指南和建议,有必要了解这一不断变化的形势以及这些药物所带来的实际临床和健康经济潜力。值得注意的是,风湿病学家将处于使用生物类似单克隆抗体/可溶性受体的前沿。生物类似药可为我们的患者节省成本并带来健康益处,将在治疗风湿性疾病中发挥重要作用。我们希望这些较低的成本能够弥补因各国经济差异导致的治疗可及性不平等。由于已获批的生物类似药已证明具有高度相似的疗效,因此在各国建立足以监测上市后长期安全性的药物警戒数据库将最为重要。