An update on the adalimumab biosimilar landscape following the approval of the first high-concentration biosimilar.
Enrico FusaroPatrick DurezJohannes WohlrabSoohyun LeeSangwook YoonHubert MarottePublished in: Immunotherapy (2021)
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.
Keyphrases
- rheumatoid arthritis
- juvenile idiopathic arthritis
- hidradenitis suppurativa
- healthcare
- ulcerative colitis
- end stage renal disease
- disease activity
- ejection fraction
- drug administration
- newly diagnosed
- chronic kidney disease
- peritoneal dialysis
- computed tomography
- transcription factor
- drug delivery
- case report
- prognostic factors
- single cell
- patient reported outcomes
- social media
- positron emission tomography
- combination therapy