Comparability between a biosimilar and its reference product requires the evaluation of critical quality attributes that may impact\non its pharmacological response. Herein we present a physicochemical characterization of a biosimilar trastuzumab focused on\nthe attributes related to the pharmacokinetic response. Capillary isoelectrofocusing (cIEF) and cation exchange chromatography\n(CEX) were used to evaluate charge heterogeneity; glycosylation profiles were assessed through hydrophilic interaction liquid\nchromatography (HILIC); aggregates content was evaluated through size exclusion chromatography (SEC) while binding affinity to\nFcRn was evaluated using isothermal titration calorimetry (ITC). The biosimilar trastuzumab and its reference product exhibited a\nhigh degree of similarity for the evaluated attributes. In regard to the pharmacokinetic parameters, randomized, double blind, and\ntwo-arm parallel and prospective study was employed after the administration of a single intravenous dose in healthy volunteers.\nNo significant differences were found between the pharmacokinetic profiles of both products. Our results confirm that similarity\nof the critical quality attributes between a biosimilar product, obtained from a different manufacturing process, and the reference\nproduct resulted in comparable pharmacokinetic profiles, diminishing the uncertainty related to the biosimilar�s safety and efficacy.
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