期刊
BIOLOGICALS
卷 58, 期 -, 页码 7-15出版社
ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.biologicals.2018.12.002
关键词
Adalimumab; Biosimilar; Humira; SB5; Imraldi; Samsung Bioepis
资金
- Samsung Bioepis Co., Ltd.
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 (R)). Extensive characterization studies were performed to demonstrate functional similarity of SB5 to reference adalimumab (Humira (R), AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG). SB5 and Humira (R) showed highly similar soluble TNF-alpha binding and neutralizing activity, as well as transmembrane TNF-alpha binding activity and reverse signaling induced in the membrane TNF-alpha 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-alpha, such as cytokine release and expression of adhesion molecules, were analyzed and shown to be similar between SB5 and Humira (R). Taken together, our results demonstrate that SB5 and Humira (R) are highly similar in terms of their functional characteristics.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据