![](/images/graphics-bg.png)
Parallelism of Chemicostructural Properties between Filgrastim Originator and Three of Its Biosimilar Drugs
Joint Authors
Memo, M.
Gianoncelli, Alessandra
Bertuzzi, Michela
Guarienti, Michela
Vezzoli, Sara
Bonini, Sara Anna
Mastinu, Andrea
Sigala, Sandra
Source
Issue
Vol. 2019, Issue 2019 (31 Dec. 2019), pp.1-15, 15 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2019-02-27
Country of Publication
Egypt
No. of Pages
15
Main Subjects
Abstract EN
The approval and granting of marketing authorization for a putative biosimilar is based on strong comparability studies with its biological reference product.
This is due to the complexity of the structure and nature of the manufacturing process of biological drugs.
Hence, a rigorous analytical workflow for chemical characterization and clinical trials to evaluate the efficacy and safety is required to demonstrate their high similarities to the reference drug.
This work is focused on the comparison of the originator of filgrastim with three of its biosimilars by evaluating their structural similarity and biological activity.
Qualiquantitative analyses were performed by MALDI-TOF/TOF-MS and RP-HPLC-UV.
An innovative functional assay using zebrafish as the animal model was developed to evaluate the biological activities of the drugs.
The different analyses performed in this study highlighted the structural similarity of biosimilar drugs and their originator.
This result was further confirmed by a similar in vivo biological activity.
American Psychological Association (APA)
Gianoncelli, Alessandra& Bertuzzi, Michela& Guarienti, Michela& Vezzoli, Sara& Bonini, Sara Anna& Mastinu, Andrea…[et al.]. 2019. Parallelism of Chemicostructural Properties between Filgrastim Originator and Three of Its Biosimilar Drugs. Journal of Chemistry،Vol. 2019, no. 2019, pp.1-15.
https://search.emarefa.net/detail/BIM-1170764
Modern Language Association (MLA)
Gianoncelli, Alessandra…[et al.]. Parallelism of Chemicostructural Properties between Filgrastim Originator and Three of Its Biosimilar Drugs. Journal of Chemistry No. 2019 (2019), pp.1-15.
https://search.emarefa.net/detail/BIM-1170764
American Medical Association (AMA)
Gianoncelli, Alessandra& Bertuzzi, Michela& Guarienti, Michela& Vezzoli, Sara& Bonini, Sara Anna& Mastinu, Andrea…[et al.]. Parallelism of Chemicostructural Properties between Filgrastim Originator and Three of Its Biosimilar Drugs. Journal of Chemistry. 2019. Vol. 2019, no. 2019, pp.1-15.
https://search.emarefa.net/detail/BIM-1170764
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1170764