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Review
. 2025 Mar;42(3):1360-1392.
doi: 10.1007/s12325-024-03098-z. Epub 2025 Feb 5.

Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review

Piotr Wiland  1 , Charlotte Both  2 , Norman B Gaylis  3 , Russell D Cohen  4 , Jonas Halfvarson  5 , Lena Lemke  2 , Oliver von Richter  2 , Andrew Blauvelt  6   7
Affiliations
Review

Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review

Piotr Wiland et al. Adv Ther. 2025 Mar.

Erratum in

Abstract

Sandoz-adalimumab (SDZ-ADL; Hyrimoz®, GP2017) is an adalimumab (ADL) biosimilar approved for the treatment of immune-mediated inflammatory diseases. Here, we review the available literature on SDZ-ADL from controlled and real-world evidence studies. A literature search was carried out to identify articles published up to July 2023 reporting data on efficacy, safety, immunogenicity, and treatment retention rates for SDZ-ADL. In randomized clinical trials, the efficacy, safety, and immunogenicity of SDZ-ADL were comparable to those observed for reference-adalimumab (ref-ADL) and not altered after single or multiple drug switches. Real-world studies confirmed the effectiveness and safety of treatment initiation with SDZ-ADL and of switching to SDZ-ADL from ref-ADL or from other ADL biosimilars. This literature review provides evidence that SDZ-ADL is as effective and safe as ref-ADL in both biologic-naïve and biologic-experienced patients.

Keywords: Adalimumab; Arthritis; Biosimilar; GP2017; Hyrimoz; Inflammatory bowel disease; Psoriasis; Sandoz-adalimumab; Spondyloarthritis.

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Conflict of interest statement

Declarations. Conflict of interest: Piotr Wiland has served as a speaker and/or advisory board member for AbbVie, AstraZeneca, Bristol Myers Squibb (BMS), Novartis, Pierre Fabre, Pfizer, Sandoz, Sobi, and UCB. Norman B. Gaylis has no conflicts of interest to declare. Charlotte Both was an employee of Hexal AG at the time of manuscript development and is a current employee of Grünenthal. Russell D. Cohen has served on the speakers’ bureau for AbbVie, BMS/Celgene, and Takeda; is a consultant for AbbVie, BMS/Celgene, Eli Lilly and Company, Genentech, Gilead Sciences, Hoffmann La-Roche, Janssen, Pfizer, Takeda, and UCB Pharma; and is a clinical trials investigator for AbbVie, BMS/Celgene, Boehringer Ingelheim, Crohn’s & Colitis Foundation of America, Genentech, Gilead Sciences, Hollister, MedImmune, Mesoblast Ltd., Osiris Therapeutics, Pfizer, Receptos, RedHill Biopharma, Sanofi-Aventis, Schwarz Pharma, Seres Therapeutics, Takeda Pharma, and UCB Pharma. Jonas Halfvarson has served as a speaker and/or advisory board member for AbbVie, Aqilion, BMS, Celgene, Celltrion, Dr Falk Pharma and the Falk Foundation, Ferring, Galapagos, Gilead, Hospira, Index Pharma, Janssen, MEDA, Medivir, Medtronic, MSD, Novartis, Pfizer, Prometheus Laboratories Inc., Sandoz, Shire, Takeda, Thermo Fisher Scientific, Tillotts Pharma, Vifor Pharma, and UCB; and has received grant support from Janssen, MSD, and Takeda. Lena Lemke was an employee of Hexal AG at the time of manuscript development. Oliver von Richter is an employee of Hexal AG. Andrew Blauvelt has served as a speaker (received honoraria) for AbbVie, Eli Lilly and Company, Pfizer, and UCB; has served as a scientific advisor (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor; and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. Ethical Approval: This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Figures

Fig. 1
Fig. 1
Pooled number of patients receiving SDZ-ADL from real-world evidence by type of treatment and by indications. ADL adalimumab, IBD inflammatory bowel disease, n number of patients, PsA psoriatic arthritis, PsO psoriasis, RA rheumatoid arthritis, ref-ADL reference-adalimumab, SDZ-ADL Sandoz-adalimumab, SpA spondyloarthritis. Data stratified by patients who were ADL-naïve, those who switched from ref-ADL, those who switched from other ADL biosimilars, and those who switched back to ref-ADL. Figure excludes 90 patients with PsO reported by Puig et al. [14], who switched from a previous biologic treatment to SDZ-ADL. aIncludes 186 patients from pooled DERMBIO data who switched to SDZ-ADL, bColaci et al. [27] report back-switchers from all chronic arthritis indications combined
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