An update on the adalimumab biosimilar landscape following the approval of the first high-concentration biosimilar.
adalimumab biosimilar
high-concentration formulation
immune-mediated inflammatory disease
pharmacokinetics
tumor necrosis factor-alpha inhibitor
Journal
Immunotherapy
ISSN: 1750-7448
Titre abrégé: Immunotherapy
Pays: England
ID NLM: 101485158
Informations de publication
Date de publication:
06 Dec 2021
06 Dec 2021
Historique:
entrez:
6
12
2021
pubmed:
7
12
2021
medline:
7
12
2021
Statut:
aheadofprint
Résumé
Biosimilars can reduce healthcare costs and expand patient access to biologic therapies. Currently, eight adalimumab biosimilars have received regulatory approval from the EMA and/or the US FDA. Following recent EMA approval of the first high-concentration adalimumab biosimilar, CT-P17, this review provides a contemporary update on adalimumab biosimilars currently licensed in Europe and the USA. The totality of evidence from each clinical development program is summarized, and characteristics of each formulation and/or device that potentially affect the convenience of treatment for patients are discussed. Future perspectives are considered, including the potential impact of the FDA's first interchangeability designation for an adalimumab biosimilar, ahead of their entry into the US marketplace in 2023.
Identifiants
pubmed: 34865524
doi: 10.2217/imt-2021-0271
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Celltrion Healthcare Co., Ltd