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Physicochemical and Biological Characterization of a Biosimilar Trastuzumab
Joint Authors
López-Morales, Carlos A.
Miranda-Hernández, Mariana P.
Juárez-Bayardo, L. Carmina
Ramírez-Ibáñez, Nancy D.
Piña-Lara, Nelly
Campos-García, Víctor R.
Romero-Díaz, Alexis J.
Pérez, Néstor O.
Medina-Rivero, Emilio
Flores-Ortiz, Luis F.
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-05-17
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
López-Morales, Carlos A.& Miranda-Hernández, Mariana P.& Juárez-Bayardo, L. Carmina& Ramírez-Ibáñez, Nancy D.& Romero-Díaz, Alexis J.& Piña-Lara, Nelly…[et al.]. 2015. Physicochemical and Biological Characterization of a Biosimilar Trastuzumab. BioMed Research International،Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1055450
Modern Language Association (MLA)
López-Morales, Carlos A.…[et al.]. Physicochemical and Biological Characterization of a Biosimilar Trastuzumab. BioMed Research International No. 2015 (2015), pp.1-10.
https://search.emarefa.net/detail/BIM-1055450
American Medical Association (AMA)
López-Morales, Carlos A.& Miranda-Hernández, Mariana P.& Juárez-Bayardo, L. Carmina& Ramírez-Ibáñez, Nancy D.& Romero-Díaz, Alexis J.& Piña-Lara, Nelly…[et al.]. Physicochemical and Biological Characterization of a Biosimilar Trastuzumab. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1055450
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1055450