Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira®.

Détails

ID Serval
serval:BIB_07EF267FC952
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Vulgarisation: article de la presse quotidienne ou article de vulgarisation scientifique.
Collection
Publications
Titre
Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira®.
Périodique
mAbs
Auteur(s)
Magnenat L., Palmese A., Fremaux C., D'Amici F., Terlizzese M., Rossi M., Chevalet L.
ISSN
1942-0870 (Electronic)
ISSN-L
1942-0862
Statut éditorial
Publié
Date de publication
01/2017
Peer-reviewed
Oui
Volume
9
Numéro
1
Pages
127-139
Langue
anglais
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
Biosimilars are biological products that are highly similar to existing products approved by health authorities. Demonstration of similarity starts with the comprehensive analysis of the reference product and its proposed biosimilar at the physicochemical and functional levels. Here, we report the results of a comparative analysis of a proposed biosimilar adalimumab MSB11022 and its reference product, Humira®. Three batches of MSB11022 and up to 23 batches of Humira® were analyzed by a set of state-of-the-art orthogonal methods. Primary and higher order structure analysis included N/C-terminal modifications, molecular weight of heavy and light chains, C-terminal lysine truncation, disulfide bridges, secondary and tertiary structures, and thermal stability. Purity ranged from 98.4%-98.8% for MSB11022 batches (N = 3) and from 98.4%-99.6% for Humira® batches (N = 19). Isoform analysis showed 5 isoform clusters within the pI range of 7.94-9.14 and 100% glycan site occupancy for both MSB11022 and Humira®. Functional analysis included Fab-dependent inhibition of tumor necrosis factor (TNF)-induced cytotoxicity in L929-A9 cell line and affinity to soluble and transmembrane forms of TNF, as well as Fc-dependent binding to Fcγ and neonatal Fc receptors and C1q complement proteins. All tested physicochemical and functional parameters demonstrated high similarity of MSB11022 and Humira®, with lower variability between MSB11022 and Humira® batches compared with variability within individual batches of Humira®. Based on these results, MSB11022 is anticipated to have safety and efficacy comparable to those of Humira®.
Mots-clé
Adalimumab/chemistry, Animals, Antirheumatic Agents/chemistry, Biosimilar Pharmaceuticals/chemistry, Humans, FcR, Humira®, MSB11022, TNF, adalimumab, analytical similarity, biosimilars
Pubmed
Web of science
Open Access
Oui
Création de la notice
28/10/2021 10:13
Dernière modification de la notice
28/10/2021 10:14
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