阿巴西普(Acellbia)——利妥昔单抗的生物类似药在系统性硬化症中的应用。
The Use of "Acellbia"-A Biosimilar of Rituximab in Systemic Sclerosis.
机构信息
Nasonova Research Institute of Rheumatology, Moscow, Russia.
Sechenov First Moscow State Medical University of the Ministry of Health Care of Russian Federation (Sechenov University), Moscow, Russia.
出版信息
Dokl Biochem Biophys. 2024 Aug;517(1):140-147. doi: 10.1134/S1607672924700844. Epub 2024 Jun 10.
The possibilities of modern therapy for systemic sclerosis (SSc) remains limited, since most of the used drugs do not have a disease-modifying effect. This encourages the study of new approaches that potentially affect the fundamental pathological processes underlying the disease. One example is anti-B-cell therapy, in particular rituximab (RTX). Until now RTX does not have a registration for the treatment of SSc, but there is a large positive experience of its use, which is reflected in recent meta-analyses and clinical recommendations. Complicated and expensive methods for obtaining genetically engineered biological drugs (biologics) have contributed to the emergence of more accessible biosimilars, one of which is the RTX biosimilar, Acellbia (Biocad, Russian Federation). The ''biosimilar'' versions of RTX might reduce the cost of therapy and increase patients accessibility to this treatment option. The RTX biosimilar Acellbia (ACB) has received approval in Russian Federation in 2014 for all indications held by reference RTX (including rheumatoid arthritis and ANCA-associated vasculitis).
现代系统性硬化症(SSc)的治疗选择仍然有限,因为大多数使用的药物没有疾病改善作用。这鼓励研究新的方法,这些方法可能会影响疾病的基本病理过程。一个例子是抗 B 细胞治疗,特别是利妥昔单抗(RTX)。到目前为止,RTX 尚未注册用于治疗 SSc,但已有大量使用的积极经验,这反映在最近的荟萃分析和临床建议中。获得基因工程生物药物(生物制剂)的复杂和昂贵方法促成了更易获得的生物类似物的出现,其中之一是 RTX 生物类似物,Acellbia(Biocad,俄罗斯联邦)。RTX 的“生物类似物”版本可能会降低治疗成本,并增加患者获得这种治疗选择的机会。RTX 生物类似物 Acellbia(ACB)于 2014 年在俄罗斯联邦获得批准,适用于参考 RTX 的所有适应症(包括类风湿关节炎和 ANCA 相关性血管炎)。