Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product.
Journal
Drugs in R&D
ISSN: 1179-6901
Titre abrégé: Drugs R D
Pays: New Zealand
ID NLM: 100883647
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
accepted:
11
09
2023
medline:
27
11
2023
pubmed:
13
10
2023
entrez:
13
10
2023
Statut:
ppublish
Résumé
ABP 654 is a proposed biosimilar to ustekinumab reference product (RP), a human immunoglobulin isotype class G subclass 1 kappa monoclonal antibody that acts as an antagonist of interleukin (IL)-23 and IL-12. Ustekinumab RP is indicated for the treatment of some forms of plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. ABP 654 and ustekinumab RP utilize different expression systems, and the purpose of this study was to assess analytical similarity between ABP 654 and ustekinumab RP sourced from the United States (US) and the European Union (EU). The analytical testing plan included general properties, primary structure, higher-order structure, product-related substances and impurities, particles and aggregates, biological activity, and thermal stability and degradation studies. ABP 654 was found to be analytically similar to ustekinumab RP with respect to physicochemical and biological properties, including structure, function, purity, and potency. Based on a comprehensive similarity assessment, ABP 654 was found to be similar to ustekinumab RP, notwithstanding minor physicochemical differences that are not expected to have a clinically meaningful effect on safety or efficacy.
Sections du résumé
BACKGROUND AND OBJECTIVE
OBJECTIVE
ABP 654 is a proposed biosimilar to ustekinumab reference product (RP), a human immunoglobulin isotype class G subclass 1 kappa monoclonal antibody that acts as an antagonist of interleukin (IL)-23 and IL-12. Ustekinumab RP is indicated for the treatment of some forms of plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. ABP 654 and ustekinumab RP utilize different expression systems, and the purpose of this study was to assess analytical similarity between ABP 654 and ustekinumab RP sourced from the United States (US) and the European Union (EU).
METHODS
METHODS
The analytical testing plan included general properties, primary structure, higher-order structure, product-related substances and impurities, particles and aggregates, biological activity, and thermal stability and degradation studies.
RESULTS
RESULTS
ABP 654 was found to be analytically similar to ustekinumab RP with respect to physicochemical and biological properties, including structure, function, purity, and potency.
CONCLUSIONS
CONCLUSIONS
Based on a comprehensive similarity assessment, ABP 654 was found to be similar to ustekinumab RP, notwithstanding minor physicochemical differences that are not expected to have a clinically meaningful effect on safety or efficacy.
Identifiants
pubmed: 37831372
doi: 10.1007/s40268-023-00441-7
pii: 10.1007/s40268-023-00441-7
pmc: PMC10676326
doi:
Substances chimiques
Ustekinumab
FU77B4U5Z0
Biosimilar Pharmaceuticals
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
421-438Informations de copyright
© 2023. The Author(s).
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