Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IBD center, Humanitas Research Hospital, IRCCS, Rozzano, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Autoimmun Rev. 2021 Jul;20(7):102849. doi: 10.1016/j.autrev.2021.102849. Epub 2021 May 8.
Several efforts have been made to improve the available therapeutic armamentarium of patients with immune-mediated inflammatory disorders (IMIDs) leading to the development of biobetters. To date, there is no commonly accepted definition of biobetters. Sixteen physicians with expertise in the field of IMIDs from eleven countries attended a virtual international consensus meeting to provide for the first time a definition of biobetter and to identify unmet needs on this topic. Improvements in clinical outcomes and drug pharmacology were considered crucial for the definition of biobetters, while safety profile and patient acceptability were not. In addition, an appropriate balance between clinical outcomes and costs and a shared decision between physicians and patients should guide the decision to use a biobetter. Clinical studies are required to validate the biobetter definition and to investigate their role in the management of patients with IMIDs.
已经做出了一些努力来改进免疫介导的炎症性疾病（IMIDs）患者的现有治疗方案，从而开发了生物类似药。迄今为止，还没有一个普遍接受的生物类似药定义。来自 11 个国家的 16 名在 IMIDs 领域具有专业知识的医生参加了一次虚拟国际共识会议，首次为生物类似药提供了定义，并确定了在这一主题上的未满足需求。临床结果和药物药理学的改善被认为是生物类似药定义的关键，而安全性和患者可接受性则不是。此外，在临床结果和成本之间取得适当平衡以及医生和患者之间的共同决策应该指导使用生物类似药的决定。需要进行临床研究来验证生物类似药的定义，并研究它们在治疗 IMIDs 患者中的作用。
