Department of Medicine 3, Medizinische Universitat Wien, Wien, Austria.
iMed - Research Institute for Medicines and Pharmacy Sciences, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.
RMD Open. 2019 May 21;5(1):e000900. doi: 10.1136/rmdopen-2019-000900. eCollection 2019.
Compared with the original approved biological drug on which it is based, a biosimilar has highly similar physicochemical characteristics and biological activity, as well as equivalent efficacy and no clinically meaningful differences in safety and immunogenicity. Before they are approved, biosimilars must undergo a rigorous development process using state-of-the-art technologies to establish biosimilarity to the reference biological product. After approval, biosimilars must comply with good pharmacological practices for biological drugs. Several biosimilar disease-modifying antirheumatic drugs (bsDMARDs) based on the tumour necrosis factor inhibitors adalimumab, etanercept and infliximab have been approved for use in patients with rheumatic diseases. Substantial cost savings can be made if biological-naive patients begin treatment with bsDMARDs, and patients receiving original biological DMARDs (bDMARDs) are switched to bsDMARDs. Despite the consistently similar efficacy, safety and immunogenicity of bsDMARDs relative to their respective original bDMARDs, switching from a reference bDMARD to a bsDMARD can result in nocebo responses, such as subjective increase of disease activity and pain-related adverse events. This may have a negative impact on adherence to bsDMARDs in clinical trials and clinical practice. To ensure optimal and rational integration of bsDMARDs into rheumatology practice and realise the full cost-saving efficacy of these drugs, rheumatologists must be aware that careful communication of the cost-saving efficacy and safety of bsDMARDs to their patients is the key to a successful long-term switch to bsDMARD therapy.
与原研生物药相比，生物类似药具有高度相似的理化特性和生物学活性，以及等效的疗效，在安全性和免疫原性方面无临床意义差异。在获得批准之前，生物类似药必须采用最先进的技术进行严格的开发过程，以建立与参比生物制品的相似性。获得批准后，生物类似药必须符合生物药物的良好药理学规范。已经批准了几种基于肿瘤坏死因子抑制剂阿达木单抗、依那西普和英夫利昔单抗的生物类似疾病修饰抗风湿药物（bsDMARDs）用于治疗风湿性疾病患者。如果生物初治患者开始使用 bsDMARDs 治疗，可以节省大量成本，并且接受原始生物 DMARDs（bDMARDs）治疗的患者可以转为 bsDMARDs。尽管 bsDMARDs 相对于其各自的原始 bDMARDs 具有一致的等效疗效、安全性和免疫原性，但从参考 bDMARD 转换为 bsDMARD 可能会导致安慰剂反应，例如疾病活动和与疼痛相关的不良事件的主观增加。这可能会对 bsDMARDs 在临床试验和临床实践中的依从性产生负面影响。为了确保 bsDMARDs 最佳且合理地融入风湿病实践，并实现这些药物的全部节省成本疗效，风湿病医生必须意识到，向患者仔细传达 bsDMARDs 的节省成本疗效和安全性是成功长期转为 bsDMARD 治疗的关键。
