Yamaguchi Teruhide
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2014(132):36-46.
Monoclonal antibody products and monoclonal antibody-based biopharmaceuticals have shown considerable effectiveness in the treatment for variety of diseases; cancer, auto-immune/auto-inflammation diseases and so on. Significant advance in monoclonal antibody products for cancer treatments was made with antibody-drug conjugates (ADC), and antibodies for blockade of immune checkpoints. Already 3 ADCs and 2 anti-immune-checkpoint antibodies products have been approved, and these monoclonal antibody-related product pipelines reach over 30. On the other hand, EU approved first monoclonal-antibody biosimilar, RemsimaTM (infliximab), suggesting that other monoclonal-antibody biosmilars will follow to the market. In this paper, several new issues about monoclonal antibody products will be discussed.
单克隆抗体产品和基于单克隆抗体的生物制药在多种疾病的治疗中已显示出显著疗效，如癌症、自身免疫/自身炎症性疾病等。抗体药物偶联物（ADC）以及免疫检查点阻断抗体在癌症治疗的单克隆抗体产品方面取得了重大进展。已有3种ADC和2种抗免疫检查点抗体产品获批，这些与单克隆抗体相关的产品管线超过30种。另一方面，欧盟批准了首个单克隆抗体生物类似药RemsimaTM（英夫利昔单抗），这表明其他单克隆抗体生物类似药也将陆续上市。本文将讨论有关单克隆抗体产品的几个新问题。
