Lee JongAh Joanne, Yang Junmo, Lee Changsoo, Moon Youngjin, Ahn Sehee, Yang Jiyoon
Bioanalysis Team, Samsung Bioepis Co., Ltd., 107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.
Bioanalysis Team, Samsung Bioepis Co., Ltd., 107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.
Biologicals. 2019 Mar;58:7-15. doi: 10.1016/j.biologicals.2018.12.002. Epub 2019 Feb 8.
A biosimilar is a biological medicinal product that is highly similar to an authorized biological product in terms of quality, biological activity, safety and efficacy. SB5 was developed by Samsung Bioepis as a biosimilar referencing adalimumab, and was authorized by the European Commission (EC) in August 2017 (Imraldi). Extensive characterization studies were performed to demonstrate functional similarity of SB5 to reference adalimumab (Humira, AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG). SB5 and Humira showed highly similar soluble TNF-α binding and neutralizing activity, as well as transmembrane TNF-α binding activity and reverse signaling induced in the membrane TNF-α expressing cell line. Both products exhibited similar binding of the Fc gamma receptors and Fc-related effector functions such as antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In addition, additional mechanisms of action induced by TNF-α, such as cytokine release and expression of adhesion molecules, were analyzed and shown to be similar between SB5 and Humira. Taken together, our results demonstrate that SB5 and Humira are highly similar in terms of their functional characteristics.
生物类似药是一种在质量、生物活性、安全性和有效性方面与已获授权的生物制品高度相似的生物药品。SB5由三星生物制剂公司研发，是参照阿达木单抗的生物类似药，并于2017年8月获得欧盟委员会（EC）批准（商品名Imraldi）。开展了广泛的特性研究以证明SB5与参照阿达木单抗（修美乐，艾伯维公司及艾伯维德国有限公司）功能相似。SB5和修美乐表现出高度相似的可溶性肿瘤坏死因子-α（TNF-α）结合及中和活性，以及跨膜TNF-α结合活性和在表达膜TNF-α的细胞系中诱导的反向信号传导。两种产品在Fcγ受体结合及Fc相关效应功能（如抗体依赖性细胞介导的细胞毒性作用（ADCC）和补体依赖性细胞毒性作用（CDC））方面表现相似。此外，对TNF-α诱导的其他作用机制（如细胞因子释放和黏附分子表达）进行了分析，结果显示SB5和修美乐之间相似。综上所述，我们的结果表明SB5和修美乐在功能特性方面高度相似。
