Real-World Data Shows Similar Clinical Outcomes in Patients Receiving Biosimilars Following Switch From Reference Product

Patients with inflammatory conditions achieved similar clinical outcomes after switching from the reference adalimumab (Humira; AbbVie) to a biosimilar, according to real-world data presented at the 2025 American Society of Health-System Pharmacists Pharmacy Futures Meeting. The research also demonstrated that no patients were hospitalized to treat their inflammatory condition during the study period.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 a prescription medicine indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, Crohn disease, ulcerative colitis, and chronic plaque psoriasis.²

There are several FDA-approved adalimumab biosimilars—including interchangeable products—that are available to patients. They are biologic medications that are highly similar to their reference products without having any clinically meaningful differences. Often, they 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.³

Oftentimes, individual payer policies can influence the preference for a reference product, biosimilar, or interchangeable biosimilar, wrote the authors, which impacts a patient and health care professional's drug selection. Although interchangeable biosimilars are expected to yield the same clinical results as their reference products, real-world data on the reversion rates of patients who transitioned from Humira to biosimilar agents is limited.¹

For these reasons, the authors conducted this study to evaluate the clinical success and patient outcomes following the mandatory conversion from Humira to a biosimilar because of insurance-related restrictions. This single-center, retrospective, observational study included data from electronic health records and specialty pharmacies from January 1, 2023, to June 1, 2024, with specialty pharmacy dispensing data specifically used to identify patients who had received Humira and a biosimilar during the study period.¹

The primary objective was to evaluate the rate of reversion to the reference product 3 months following the switch to a biosimilar. Secondary objectives included the following: changes in quality of life (QOL) scores, which were measured using specific disease state questionnaires, and the number of flares that required hospitalization in patients who transitioned from Humira to a biosimilar. Additionally, when applicable, average steroid usage was measured in prednisone equivalents.¹

Specialty pharmacy dispensing data identified 67 patients with a diverse range of inflammatory conditions for study screening, and of this group, only 32 had eligibility criteria for enrollment. The most common reason for exclusion was the patient opting out of clinical follow-up with the specialty pharmacy team.¹

Thirty of the patients were switched from Humira to the interchangeable biosimilar adalimumab-bwwd (Hadlima; Samsung Bioepis), whereas the remaining 2 were switched to adalimumab-adaz (Hyrimoz; Sandoz). Both Hadlima and Hyrimoz share the same strengths and dosages and have no clinically meaningful differences from Humira when relieving patient symptoms.^1,4,5

The investigators observed that approximately 9% of patients had reverted back to Humira following 3 months, and the remaining 91% remained on Hadlima or Hyrimoz or transitioned to an alternative product. Regarding secondary outcomes, there were no patients who were hospitalized during the study period for treatment of their inflammatory condition. Among the 19 patients who had available QoL data recorded both prior to and following treatment transition, 12 had reported either improvement or no change in their initial QoL scores. Conversely, 7 noted experiencing worsened measures. Further, of the 4 patients who used chronic oral corticosteroids, 3 had no change or a reduction in the daily prednisone milligram equivalents, whereas 1 had experienced an initial increase in steroid dose following the switch to a biosimilar.¹

The findings indicate that most patients achieve similar clinical outcomes after transitioning from Humira to Hadlima, Hyrimoz, or another biosimilar. Compared with clinical trial data, these data may have different implications or significance because of their real-world nature.¹

Of note, the investigators write that previously published surveys of patients treated with biologic therapies show concerns that switching to a biosimilar for nonmedical reasons would result in worsened disease control and side effects, creating a potential and preemptive bias against biosimilars. They explain that in this current study, the higher-than-expected reversion rate observed in this study may reflect a “preemptive bias rather than true clinical differences” between biosimilars and their reference product.¹

REFERENCES

1. Mountain J, DaCosta SS, Zuern A. (38-M) Clinical Success in Treating Inflammatory Conditions after Adalimumab Biosimilar Conversion. Presented at: American Society of Health-System Pharmacists 2025 Pharmacy Futures Meeting. Charlotte, North Carolina. June 7–11.

2. Humira. Humira – adalimumab. Accessed June 26, 2025. https://www.humira.com/

3. McGovern G. Understanding Biologics and Biosimilars Amid an Evolving Treatment Landscape. Pharmacy Times. June 12, 2025. Accessed June 26, 2025. https://www.pharmacytimes.com/view/understanding-biologics-and-biosimilars-amid-an-evolving-treatment-landscape

4. Hadlima (adalimumab-bwwd). What is Hadlima? Accessed June 26, 2025. https://www.hadlima.com/what-is-hadlima/

5.Sandoz. Hyrimoz — adalimumab-adaz. Accessed June 26, 2025. https://www.hyrimoz.com/#:~:text=What%20can%20you%20expect%20with%20HYRIMOZ%20(adalimumab%2Dadaz)%3F