Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira.

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.