Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians
- PMID: 40263151
- PMCID: PMC12185648
- DOI: 10.1007/s40259-025-00719-z
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians
Abstract
Ten adalimumab biosimilars have been introduced in the United States (USA) since 2023, while adalimumab biosimilars have been available for several years in other countries. These experiences of biosimilar uptake outside the USA can inform US-based healthcare professionals on switching in real-life practice settings. Considerations include how healthcare professionals might meaningfully address patient concerns about outcomes to improve patient satisfaction. A search of the MEDLINE database was used to identify publications on switching to and among adalimumab biosimilars in an ex-US setting, with no restriction on publication language and using a time frame of 1 January 2017 through 12 December 2023, coinciding with the European Union approval of the first adalimumab biosimilar, adalimumab-atto, in March 2017. This narrative review aims to provide insights into the efficacy and safety of transitioning to and among adalimumab biosimilars in adult patients from clinical studies but also, more importantly, using real-world evidence (RWE) from outside the USA. Overall, RWE suggested that efficacy and outcomes were consistent in patients who underwent switching from the reference product (RP) across various immune-mediated inflammatory diseases when compared to patients who did not switch from the RP. The ex-US RWE of RP and biosimilar adalimumab switches generally reflected the experiences observed in clinical trials; however, RWE findings elucidated several challenges to biosimilar uptake, including patient education, provider training, and supportive policies.
© 2025. The Author(s).
Conflict of interest statement
Declarations. Funding: This work was supported by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. The authors received no payment related to the development of the manuscript. Conflict of interest: JRPT is a consultant for Abbvie, Amgen, Boehringer Ingelheim, and Pfizer, is part of the speaker bureau for Abbvie, Amgen, and Pfizer, and has received research grants from Abbvie, Amgen, Biogen, Boehringer Ingelheim, and Pfizer. AC is a consultant and/or advisory board member for Abbvie, Boehringer Ingelheim, Eli Lilly, Janssen, Takeda, and Pfizer. AAH has no competing interests to declare that are relevant to the content of this article. The authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Jia Gao, PharmD, of Elevate Scientific Solutions LLC, provided medical writing, editorial support, and formatting support, which were contracted and funded by BIPI. Data availability statement: Not applicable. Ethics approval: Research ethics approval was not required as no participants took part in this study. Patient consent to participate/publish: Not applicable. Code availability: Not applicable. Author contributions: JRPT, AC, and AAH contributed to the conceptualization of this review article, and subsequent literature search and interpretation of data. All authors reviewed the manuscript for important intellectual content and approved the final version of the manuscript. The authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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References
-
- FDA. Purple book: database of licensed biological products. https://purplebooksearch.fda.gov/. Accessed 12 July 2024.
-
- IQVIA. Adalimumab biosimilar tracking. 2024. https://biosimilarscouncil.org/wp-content/uploads/2024/08/202408-IQVIA-A.... Accessed 23 Jan 2025.
-
- GaBI-Generics and Biosimilars Initiative. Biosimilars approved in Europe 2020. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Eu.... Accessed 3 Jan 2024.
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