Department of Medicine, University of Colorado Denver - Anschutz Medical Campus, 12631 East 17th Avenue, Aurora, CO 80045, USA.
Department of Medicine, Division of Rheumatology, University of Colorado Denver - Anschutz Medical Campus, 12631 East 17th Avenue, Aurora, CO 80045, USA.
Curr Opin Pharmacol. 2022 Jun;64:102234. doi: 10.1016/j.coph.2022.102234. Epub 2022 May 9.
Biologics are effective, though costly, medications for the treatment of rheumatoid arthritis (RA). Biosimilars are medications that have no clinically meaningful differences when compared with their corresponding reference biologics but cost significantly less. The U.S. Food and Drug Administration and the European Medication Agency have approved biosimilars for adalimumab, etanercept, infliximab, and rituximab for the treatment of RA. Streamlined approval processes are expected to expedite biosimilar development while maintaining strict safety and efficacy standards. Encouragingly, many analyses have demonstrated the potential for massive healthcare savings if biosimilars are used over biologics. Challenges to biosimilar uptake, including patient and provider hesitancy, can likely be overcome with the education of all stakeholders within healthcare systems.
生物制剂是治疗类风湿关节炎 (RA) 的有效药物，尽管价格昂贵。生物类似药是指与相应的参照生物制剂相比没有临床意义差异，但价格却显著降低的药物。美国食品药品监督管理局和欧洲药品管理局已经批准了阿达木单抗、依那西普、英夫利昔单抗和利妥昔单抗的生物类似药，用于治疗 RA。简化的审批流程有望在保持严格的安全性和疗效标准的同时，加快生物类似药的开发。令人鼓舞的是，如果生物类似药得到广泛应用，许多分析表明，它们具有巨大的节省医疗保健费用的潜力。生物类似药的采用面临一些挑战，包括患者和提供者的犹豫，这些挑战可能通过在医疗保健系统内对所有利益相关者进行教育来克服。
