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BioMed Research International
Volume 2015 (2015), Article ID 427235, 10 pages
http://dx.doi.org/10.1155/2015/427235
Research Article

Physicochemical and Biological Characterization of a Biosimilar Trastuzumab

1Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico
2MUHC Research Institute, Royal Victoria Hospital, McGill University, 687 Pine Avenue West, Montreal, QC, Canada H3A 1A1

Received 11 October 2014; Revised 10 March 2015; Accepted 24 March 2015

Academic Editor: Pedro H. Oliveira

Copyright © 2015 Carlos A. López-Morales et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

According to the World Health Organization, the incidence of malignant neoplasms and endocrine, blood, and immune disorders will increase in the upcoming decades along with the demand of affordable treatments. In response to this need, the development of biosimilar drugs is increasing worldwide. The approval of biosimilars relies on the compliance with international guidelines, starting with the demonstration of similarity in their physicochemical and functional properties against the reference product. Subsequent clinical studies are performed to demonstrate similar pharmacological behavior and to diminish the uncertainty related to their safety and efficacy. Herein we present a comparability exercise between a biosimilar trastuzumab and its reference product, by using a hierarchical strategy with an orthogonal approach, to assess the physicochemical and biological attributes with potential impact on its pharmacokinetics, pharmacodynamics, and immunogenicity. Our results showed that the high degree of similarity in the physicochemical attributes of the biosimilar trastuzumab with respect to the reference product resulted in comparable biological activity, demonstrating that a controlled process is able to provide consistently the expected product. These results also constitute the basis for the design of subsequent delimited pharmacological studies, as they diminish the uncertainty of exhibiting different profiles.