Across major evidence-based treatment guidelines covering various Food and Drug Administration (FDA)-approved indications, adalimumab is generally addressed at the tumor necrosis factor (TNF) inhibitor or biologic class level, with recommendations focused on biologic classes rather than individual branded products. Within these guidelines, reference adalimumab and biosimilars are not given separate recommendations or differentiated treatment pathways. [1-10]
A 2025 comprehensive literature review synthesizing controlled trials and real-world evidence evaluated the efficacy, safety, and immunogenicity of SDZ-ADL (Sandoz adalimumab biosimilar, Hyrimoz®/GP2017) in biologic-naïve and biologic-experienced patients with immune-mediated inflammatory diseases. A structured literature search (up to July 2023) identified 15 peer-reviewed studies and 6 congress abstracts for inclusion (see Table 3), encompassing 923 patients from randomized controlled trials (RCTs) and over 2800 patients f...
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[1] Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2021;73(7):1108-1123. doi:10.1002/art.41752
[2] Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960-977. doi:10.1136/annrheumdis-2016-210715
[3] Singh JA, Guyatt G, Ogdie A, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726
[4] Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2019;71(10):1285-1299. doi:10.1002/acr.24025
[5] Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087
[6] Zouboulis CC, Desai N, Emtestam L, et al. European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015;29(4):619-644. doi:10.1111/jdv.12966
[7] Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018;113(4):481-517. doi:10.1038/ajg.2018.27
[8] Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114(3):384-413. doi:10.14309/ajg.0000000000000152
[9] Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Oligoarthritis, Temporomandibular Joint Arthritis, and Systemic Juvenile Idiopathic Arthritis. Arthritis Care Res (Hoboken). 2022;74(4):521-537. doi:10.1002/acr.24853
[10] Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81(1):91-101. doi:10.1016/j.jaad.2019.02.068
[11] Wiland P, Both C, Gaylis NB, Cohen RD, Halfvarson J, Lemke L, von Richter O, Blauvelt A. Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review. Adv Ther. 2025 Mar;42(3):1360-1392. doi: 10.1007/s12325-024-03098-z.
[12] Li C, Sunhe Y, Zhou H, Dong W. Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis. J Dermatolog Treat. 2023 Dec;34(1):2249145. doi: 10.1080/09546634.2023.2249145.
[13] Yiu CH, Or CH, Almutairi K, Raubenheimer J, Day RO, Lu CY. Comparative efficacy, safety and immunogenicity of biosimilars and their reference biologic drugs in ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials. Expert Opin Biol Ther. 2025;25(7):761-771. doi:10.1080/14712598.2025.2512126
[14] Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021;8(1):41-61. doi:10.1007/s40744-020-00259-8
[15] Lu X, Hu R, Peng L, Liu M, Sun Z. Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis. Front Immunol. 2021;12:638444. Published 2021 Apr 6. doi:10.3389/fimmu.2021.638444
[16] Zhao S, Chadwick L, Mysler E, Moots RJ. Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. Curr Rheumatol Rep. 2018 Aug 9;20(10):57. doi: 10.1007/s11926-018-0769-6.
[17] Ascef BO, Almeida MO, Medeiros-Ribeiro AC, Oliveira de Andrade DC, Oliveira Junior HA, de Soárez PC. Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023;6(5):e2315872. Published 2023 May 1. doi:10.1001/jamanetworkopen.2023.15872