An update on the adalimumab biosimilar landscape following approval of the first high-concentration biosimilar-Reference-Cited by-同舟云学术

An update on the adalimumab biosimilar landscape following approval of the first high-concentration biosimilar

Published:2022-02 Issue:3 Volume:14 Page:235-252
ISSN:1750-743X
Container-title:Immunotherapy
language:en
Short-container-title:Immunotherapy

Author:

Fusaro Enrico¹^ORCID,Durez Patrick²^ORCID,Wohlrab Johannes³^ORCID,Lee Soohyun⁴^ORCID,SangWook Yoon ⁴^ORCID,Marotte Hubert⁵^ORCID

Affiliation:

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

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

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

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

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

Abstract

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.

Funder

Celltrion Healthcare Co., Ltd

Publisher

Future Medicine Ltd

Subject

Oncology,Immunology,Immunology and Allergy

Link

https://www.futuremedicine.com/doi/pdf/10.2217/imt-2021-0271

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