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
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

Auteurs

Enrico Fusaro (E)

Rheumatology Unit, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, 10126, Torino, Italy.

Patrick Durez (P)

Rheumatology, Cliniques Universitaires Saint-Luc - Université catholique de Louvain - Institut de Recherche Expérimentale et Clinique, 1200, Brussels, Belgium.

Johannes Wohlrab (J)

Department of Dermatology and Venereology, Martin Luther University Halle-Wittenberg, D-06120, Halle, Germany.

Soohyun Lee (S)

Celltrion Healthcare Co., Ltd., 22014, Incheon, Republic of Korea.
Celltrion Healthcare Co., Ltd., 22014, Incheon, Republic of Korea.

Hubert Marotte (H)

Department of Rheumatology, Centre Hospitalier Universitaire de Saint-Etienne, CIC1408, and INSERM, U1059, 42055, Saint-Etienne, France.

Classifications MeSH