Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Feb 15;11(4):1007.
doi: 10.3390/jcm11041007.

Switching from Adalimumab Originator to Biosimilar: Clinical Experience in Patients with Hidradenitis Suppurativa

Trinidad Montero-Vilchez  1   2 , Carlos Cuenca-Barrales  1   2 , Andrea Rodriguez-Tejero  1   2 , Antonio Martinez-Lopez  1   2 , Salvador Arias-Santiago  1   2   3 , Alejandro Molina-Leyva  1   2   4
Affiliations

Switching from Adalimumab Originator to Biosimilar: Clinical Experience in Patients with Hidradenitis Suppurativa

Trinidad Montero-Vilchez et al. J Clin Med. .

Abstract

Adalimumab is currently the only biological medicine approved by the FDA for the treatment of hidradenitis suppurativa (HS). The breakout of biosimilar drugs made them more accessible due to their impact on pharmacoeconomics. However, packaging, formulation, or excipients are unique characteristics of each drug. In that way, switching from adalimumab originator to biosimilar and between biosimilars could have implications in the clinical practice. The objective of this study is to describe our clinical experience in switching from adalimumab originator to biosimilar and switching back again. A single-center retrospective cohort study was conducted that included seventeen patients with HS treated with adalimumab originator in the maintenance phase, and that achieved Hidradenitis Suppurativa Clinical Response (HiSCR), who were switched to adalimumab biosimilar for no medical reasons. The reason for the change was to improve pharmacoeconomic efficiency, following our hospital policies on biologics. Median duration with adalimumab originator treatment before switching was 48 weeks. After switching, 41.2% of patients maintained HiSCR response without additional issues, while 58.8% (10/17) reported problems after the change. Switching from adalimumab originator to biosimilar in well-controlled patients could imply problems in efficacy and adherence. Switching back to adalimumab originator appears to solve most of the problems, but some patients can lose confidence in the drug and discontinue it. It would be worthwhile to evaluate the benefit-risk ratio individually when switching an HS patient to adalimumab biosimilar.

Keywords: adalimumab; biosimilar; hidradenitis suppurativa; switching.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Patients switching flow chart.
See this image and copyright information in PMC

References

    1. Jemec G.B. Clinical practice. Hidradenitis suppurativa. N. Engl. J. Med. 2012;366:158–164. doi: 10.1056/NEJMcp1014163. - DOI - PubMed
    1. Kimball A., Sobell J., Zouboulis C.P.D., Gu Y., Williams D.A., Sundaram M., Teixeira H., Jemec G. HiSCR (Hidradenitis Suppurativa Clinical Response): A novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J. Eur. Acad. Dermatol. Venereol. 2015;30:989–994. doi: 10.1111/jdv.13216. - DOI - PMC - PubMed
    1. US Food and Drug Administration HUMIRA® (adalimumab) Injection, for Subcutaneous Use. [(accessed on 8 April 2008)];2008 Available online: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl....
    1. Puig L., Lopez-Ferrer A., Vilarrasa E., Garcia I., Fernandez-del Olmo R. Model for assessing the efficiency of biologic drugs in the treatment of moderate to severe psoriasis for one year in clinical practice in Spain. Actas Dermosifiliogr. 2016;107:34–43. doi: 10.1016/j.ad.2015.07.006. - DOI - PubMed
    1. Kim H., Alten R., Avedano L., Dignass A., Gomollón F., Greveson K., Halfvarson J., Irving P., Jahnsen J., Lakatos P., et al. The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases. Drugs. 2020;80:99–113. doi: 10.1007/s40265-020-01256-5. - DOI - PMC - PubMed