![](/images/graphics-bg.png)
Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization
Joint Authors
López-Morales, Carlos A.
Miranda-Hernández, Mariana P.
Piña-Lara, Nelly
Perdomo-Abúndez, Francisco C.
Revilla-Beltri, Jorge
Molina-Pérez, Aarón
Estrada-Marín, Larisa
Ruiz-Argüelles, Alejandro
Pérez, Néstor O.
Medina-Rivero, Emilio
Flores-Ortiz, Luis F.
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-11-19
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
Comparability between a biosimilar and its reference product requires the evaluation of critical quality attributes that may impact on its pharmacological response.
Herein we present a physicochemical characterization of a biosimilar trastuzumab focused on the attributes related to the pharmacokinetic response.
Capillary isoelectrofocusing (cIEF) and cation exchange chromatography (CEX) were used to evaluate charge heterogeneity; glycosylation profiles were assessed through hydrophilic interaction liquid chromatography (HILIC); aggregates content was evaluated through size exclusion chromatography (SEC) while binding affinity to FcRn was evaluated using isothermal titration calorimetry (ITC).
The biosimilar trastuzumab and its reference product exhibited a high degree of similarity for the evaluated attributes.
In regard to the pharmacokinetic parameters, randomized, double blind, and two-arm parallel and prospective study was employed after the administration of a single intravenous dose in healthy volunteers.
No significant differences were found between the pharmacokinetic profiles of both products.
Our results confirm that similarity of the critical quality attributes between a biosimilar product, obtained from a different manufacturing process, and the reference product resulted in comparable pharmacokinetic profiles, diminishing the uncertainty related to the biosimilar’s safety and efficacy.
American Psychological Association (APA)
Miranda-Hernández, Mariana P.& López-Morales, Carlos A.& Piña-Lara, Nelly& Perdomo-Abúndez, Francisco C.& Pérez, Néstor O.& Revilla-Beltri, Jorge…[et al.]. 2015. Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization. BioMed Research International،Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1057105
Modern Language Association (MLA)
Miranda-Hernández, Mariana P.…[et al.]. Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization. BioMed Research International No. 2015 (2015), pp.1-7.
https://search.emarefa.net/detail/BIM-1057105
American Medical Association (AMA)
Miranda-Hernández, Mariana P.& López-Morales, Carlos A.& Piña-Lara, Nelly& Perdomo-Abúndez, Francisco C.& Pérez, Néstor O.& Revilla-Beltri, Jorge…[et al.]. Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1057105
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1057105