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风湿性疾病中生物类似药英夫利昔单抗(CT-P13)的科学进展

A scientific update on biosimilar infliximab (CT-P13) in rheumatic diseases.

作者信息

Taylor Peter

机构信息

a Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK.

出版信息

Expert Rev Clin Immunol. 2015;11 Suppl 1:S1-4. doi: 10.1586/1744666X.2015.1090876.

Abstract

The development of biologic drugs has undoubtedly enhanced the spectrum of treatments available for immune-mediated inflammatory rheumatic diseases such as rheumatoid arthritis. However, despite their clear clinical benifits, use of biologics is often hindered by their high costs. The manufacture and subsequent approval of more cost-effective 'biosimilar' versions of these drugs may address this issue and improve patient access. CT-P13 (Remsima(®), Inflectra(®)), a biosimilar of infliximab (Remicade(®)), has shown comparable efficacy, safety and pharmacokinetics to its originator drug in clinical studies. The articles in this supplement present a scientific update on the development and use of biosimilars in rheumatic disorders, with specific focus on CT-P13. The information discussed highlights the predicted positive clinical and economic impact of biosimilars on the management of rheumatic diseases.

摘要

生物药物的发展无疑拓宽了类风湿关节炎等免疫介导的炎性风湿性疾病的治疗范围。然而,尽管生物药物具有明确的临床益处,但其高昂的成本常常阻碍了它们的使用。生产这些药物更具成本效益的“生物类似药”版本并随后获得批准,可能会解决这一问题并改善患者的可及性。英夫利昔单抗(类克®)的生物类似药CT-P13(雷米西马®、英利昔单抗®)在临床研究中已显示出与其原研药相当的疗效、安全性和药代动力学。本增刊中的文章提供了有关生物类似药在风湿性疾病中的研发和应用的科学进展,特别聚焦于CT-P13。所讨论的信息突出了生物类似药对风湿性疾病管理预计产生的积极临床和经济影响。

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