Extensive preclinical evaluation of an infliximab biosimilar candidate

• DOI: 10.1016/j.ejps.2017.01.038
• Publication Date: 2017-02-07T13:30:39Z
• Authors: MA. Velasco-Veláz...; N. Salinas-Jazmín; E. Hisaki-Itaya; L. Cobos-Puc; W. Xolalpa; G. González; A. Tenorio-Calvo; N. Piña-Lara; LC. Juárez-Bayardo; LF. Flores-Ortiz; E. Medina-Rivero; NO. Pérez; SM. Pérez-Tapia
• Keywords: Biosimilar

Infliximab is therapeutic monoclonal antibody (mAb) against TNF-α employed in the treatment of immunoinflammatory diseases. The development of biosimilar mAbs is a global strategy to increase drug accessibility and reduce therapy-associated costs. Herein we compared key physicochemical characteristics and biological activities produced by infliximab and infliximab-Probiomed in order to identify functionally relevant differences between the mAbs. Binding of infliximab-Probiomed to TNF-α was specific and had kinetics comparable to that of the reference product. Both mAbs had highly similar neutralizing efficacy in HUVEC cell cultures stimulated with TNF-α. In vitro induction of CDC and ADCC were also similar between the evaluated products. In vivo comparability was assessed using a transgenic mouse model of arthritis that expresses human TNF-α in a 13-week multiple-administration study. Infliximab and infliximab-Probiomed showed comparable efficacy, safety, and pharmacokinetic profiles. Our results indicate that infliximab-Probiomed has highly similar activities to infliximab in preclinical models, warranting a clinical evaluation of its biosimilarity.