title: Physicochemical and biological characterization of a biosimilar trastuzumab.
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.
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: López-Morales
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Mariana P
authors.initials: MP
authors.lastname: Miranda-Hernández
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: L Carmina
authors.initials: LC
authors.lastname: Juárez-Bayardo
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Nancy D
authors.initials: ND
authors.lastname: Ramírez-Ibáñez
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Alexis J
authors.initials: AJ
authors.lastname: Romero-Díaz
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Nelly
authors.initials: N
authors.lastname: Piña-Lara
authors.affiliation: MUHC Research Institute, Royal Victoria Hospital, McGill University, 687 Pine Avenue West, Montreal, QC, Canada H3A 1A1.
authors.forename: Víctor R
authors.initials: VR
authors.lastname: Campos-García
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Néstor O
authors.initials: NO
authors.lastname: Pérez
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Luis F
authors.initials: LF
authors.lastname: Flores-Ortiz
authors.affiliation: Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, 52400 Tenancingo, MEX, Mexico.
authors.forename: Emilio
authors.identifier: 0000-0001-8862-1378
authors.initials: E
authors.lastname: Medina-Rivero
mesh_terms: D000970:Antineoplastic Agents / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D045744:Cell Line, Tumor; D004354:Drug Screening Assays, Antitumor; D006801:Humans; D000068878:Trastuzumab / Q000737:chemistry / Q000494:pharmacology
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D000068878:Trastuzumab