Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab

Abstract

ABSTRACTBiosimilars are biologic products that are highly similar to a licensed reference product in terms of quality, safety, and efficacy. SB5 is a biosimilar of Humira® (adalimumab) developed by Samsung Bioepis. To demonstrate its biosimilarity in quality to Humira®, we performed a comprehensive characterization in terms of structure, physicochemical properties, and biological properties following the International Conference on Harmonization, US Food and Drug Administration, and European Medicines Agency guidelines. We analyzed all available batches of SB5 and more than 100 EU- and US-sourced lots of Humira® using state-of-the-art methods whenever possible, and compared the two sets of data. The structural properties comprised primary and higher-order structures and N-glycosylation. The physicochemical characteristics were categorized into liquid chromatographic patterns and electrophoretic pattern concerning size and charge heterogeneity. The biological properties were examined by in vitro functional assays.Overall, SB5 and Humira® were shown to be similar to each other in terms of quality attributes. For some of the quality attributes, minor differences were observed. However, the observed differences have been adequately addressed and demonstrated these do not translate into clinically meaningful differences in terms of safety, purity, and potency.