Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product.
Amino Acid Sequence
Antineoplastic Agents, Immunological
/ chemistry
Apoptosis
/ drug effects
Biosimilar Pharmaceuticals
/ chemistry
Cell Line, Tumor
Cell Survival
/ drug effects
Humans
Immunoglobulin Fab Fragments
/ chemistry
Jurkat Cells
Polysaccharides
/ metabolism
Protein Binding
Protein Conformation
Protein Processing, Post-Translational
Reference Standards
Rituximab
/ chemistry
ABP 798
Biosimilar
Function
Rituximab
Structure
Journal
Biologicals : journal of the International Association of Biological Standardization
ISSN: 1095-8320
Titre abrégé: Biologicals
Pays: England
ID NLM: 9004494
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
10
03
2020
revised:
29
06
2020
accepted:
03
08
2020
pubmed:
6
9
2020
medline:
31
8
2021
entrez:
5
9
2020
Statut:
ppublish
Résumé
ABP 798 is a biosimilar candidate to rituximab reference product (RP). This comprehensive analytical similarity assessment was designed to assess the structural and functional similarity of ABP 798, rituximab (US), and rituximab (EU) using sensitive state-of-the-art analytical techniques capable of detecting small differences in product attributes. The similarity assessment was performed to evaluate product quality attributes associated with Fab, Fab/Fc, and Fc domains, including those known to affect the mechanisms of action. ABP 798 has the same amino acid sequence and exhibits similar secondary and tertiary structures, similar glycan and post-translational modification profiles, and biological activities as rituximab RP. There are minor differences in biochemical attributes, which are not considered clinically meaningful. The results of the analytical and functional similarity assessment demonstrate that ABP 798 is highly analytically similar to rituximab RP. These results support the totality of evidence and the scientific justification for extrapolation of ABP 798 to all therapeutic indications approved for rituximab.
Identifiants
pubmed: 32888776
pii: S1045-1056(20)30092-0
doi: 10.1016/j.biologicals.2020.08.002
pii:
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Biosimilar Pharmaceuticals
0
Immunoglobulin Fab Fragments
0
Polysaccharides
0
Rituximab
4F4X42SYQ6
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
79-91Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.