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Updated: Oct 11, 2025

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
An update on the adalimumab biosimilar landscape following the approval of the first high-concentration biosimilar
Enrico Fusaro1, Patrick Durez2, Johannes Wohlrab3
1Rheumatology Unit, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, 10126, Torino, Italy.
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.
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