Switching From Reference Adalimumab to Biosimilar Shows No Major Differences in Patients With RA, PsA

There were no differences in disease activity, functional capacity, or radiographic progression when patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) switched from reference adalimumab (Humira; AbbVie) to a biosimilar, adalimumab-adaz (originally GP2017 and SDZ-ADL, Hyrimoz; Novartis), according to authors of research published in Reumatismo. Additionally, the authors wrote that ultrasonography indicated improved power Doppler (PD) findings.¹

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Reference adalimumab is a monoclonal antibody that inhibits tumor necrosis factor-α, a protein that contributes to inflammation. It is indicated for RA, polyarticular juvenile idiopathic arthritis, PsA, ankylosing spondylitis, hidradenitis suppurativa, Crohn disease, ulcerative colitis, and chronic plaque psoriasis. Currently, there are multiple FDA-approved adalimumab biosimilars—including interchangeable products—that are available to patients. These are biologic medications that are highly similar to their reference products without having any clinically meaningful differences. Often, biosimilars are made with the same types of living sources and given to patients via the same administration methods. It is important to note that biologics cannot be copied identically, even though the active ingredients in generic drugs are often smaller, simpler, and easier to copy.²

Approved in 2018 by the FDA, Hyrimoz has demonstrated biosimilarity in each stage of clinical investigations, according to research from a 2024 study published in Advances in Therapy. For instance, phase 1 clinical data showed pharmacokinetic similarity of Hyrimoz and Humira in healthy volunteers, with similar safety, tolerability, and immunogenicity profiles. Two phase 3 confirmatory efficacy and safety studies, ADACCESS (NCT02016105) and ADMYRA (NCT02744755), both confirmed that the efficacy, safety, and immunogenicity of Hyrimoz matched its reference product in all patient groups, without clinically meaningful differences. Of note, these data were the basis for a citrate-free high-concentration formulation of Hyrimoz to be developed, and its pharmacokinetic, safety, and immunogenicity were confirmed against the initially approved formulation of Hyrimoz.³

The authors wrote that there is limited data in Latin America that exists regarding the safety of switches from original biologics to biosimilars in real-life situations. For this study, they enrolled a prospective cohort of patients diagnosed with RA and PsA undergoing treatment with Humira. In their study, the authors aimed to evaluate clinical, functional, ultrasonographic, and radiological responses in this patient population after switching from Humira to the biosimilar Hyrimoz.¹

At a baseline visit, blood analysis, X-rays, ultrasounds, and an interview for sociodemographic and clinical data were conducted. Patients and evaluators were blinded to each other's data. Patients switched to Hyrimoz during follow-up and were assessed in the same program within 3 to 12 months following the switch (only including patients with all evaluations). Only 35 patients with RA and 15 patients with PsA met the criteria for complete pre- and post-control post-switch to Hyrimoz.¹

The findings demonstrated that the mean time between the switch and the second evaluation was about 4.1 months. There were no observed statistical differences in disease activity or functional capacity, and no differences were found in X-ray imaging erosion number; however, ultrasonography revealed decreased PD activity, but not grayscale findings. Of note, there were no differences in acute phase reactants, joint count, or patient visual analog scale observed between controls.¹

These findings are consistent with other data, such as findings from a 2025 American Society of Health-System Pharmacists Pharmacy Futures Meeting presentation, which showed similar clinical outcomes when patients with inflammatory conditions switched from Humira to Hyrimoz and adalimumab-bwwd (Hadlima; Samsung Bioepis). Similarly to the Reumatismo study, this presentation represented a cohort of real-world patients.^1,2

Such findings are a positive indication that patients being treated for RA or PsA can expect highly similar outcomes in disease activity, functional capacity, or radiographic progression when receiving treatment with Hyrimoz.^1,2 Treatment with biosimilars rather than a reference product can be a more accessible and affordable method of achieving symptomatic relief in a safe and effective way.

REFERENCES

1. Garcia-Salinas R, Magri S, Ruta A, Ruta S. A comprehensive evaluation of the transition to a biosimilar of adalimumab in rheumatoid arthritis and psoriatic arthritis: a single-center experience with a focus on imaging outcomes. Reumatismo. Published May 8, 2025. doi:10.4081/reumatismo.2025.1748

2. McGovern G. Real-World Data Show Similar Clinical Outcomes in Patients Receiving Biosimilars Following Switch From Reference Product. Pharmacy Times. July 4, 2025. Accessed August 26, 2025. https://www.pharmacytimes.com/view/real-world-data-shows-similar-clinical-outcomes-in-patients-receiving-biosimilars-following-switch-from-reference-product

3. van Adrichem RCS, Voorneveld HJE, Waverijn GJ, Kok MR, Bisoendial RJ. The Non-medical Switch from Reference Adalimumab to Biosimilar Adalimumab is Highly Successful in a Large Cohort of Patients with Stable Inflammatory Rheumatic Joint Diseases: A Real-Life Observational Study. Rheumatol Ther. 2022;9(4):1109-1118. doi:10.1007/s40744-022-00465-6.