Parallelism of Chemicostructural Properties between Filgrastim Originator and Three of Its Biosimilar Drugs

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 work...

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Bibliographic Details
Published in:Journal of chemistry 2019-01, Vol.2019 (2019), p.1-15
Main Authors: Memo, M., Mastinu, Andrea, Bonini, Sara Anna, Vezzoli, Sara, Guarienti, Michela, Bertuzzi, Michela, Gianoncelli, Alessandra, Sigala, Sandra
Format: Article
Language:English
Subjects:
Amino acids
Biological activity
Biological products
Cell adhesion & migration
Comparative analysis
Drugs
Embryos
Genomes
Granulocyte colony-stimulating factor
Granulocytes
Growth factors
High performance liquid chromatography
Medical research
Neutrophils
Organic chemistry
Peptides
Pharmaceuticals
Proteins
Similarity
Studies
Toxicology
Workflow
Zebrafish
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Summary: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.
ISSN:2090-9063
2090-9071
DOI:10.1155/2019/2751461