Switch to Biosimilar Adalimumab Found Safe and Cost-Saving for Patients With IBD

Patients with inflammatory bowel disease (IBD) who transitioned from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and generated substantial drug cost savings, according to a single-center prospective cohort study from Galway University Hospitals in Ireland.¹

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Biologic therapies such as adalimumab account for a large portion of pharmaceutical expenditures, and biosimilars have been introduced as lower-cost alternatives with comparable efficacy and safety. In Ireland, national health authorities recommend nonmedical switching to biosimilars to improve affordability and expand access. Despite these policy shifts, concerns remain that a “nocebo effect”—in which patients anticipate worse outcomes due to their negative perceptions about a drug²—could undermine confidence in biosimilars. Researchers sought to explore these clinical, psychological, and economic dynamics during a structured switch to Amgevita.²

Seventy-one individuals with IBD were initially recruited, of whom 64 were included in the final analysis. Participants ranged in age from 18 to 67 years, with an average disease duration of 12 years and mean Humira use of nearly 4 years. Most participants had Crohn disease (78%), while others had ulcerative colitis (17%) or indeterminate colitis (5%). Clinical status was measured with standard indices, including the Harvey–Bradshaw Index and partial Mayo score, as well as fecal calprotectin and C-reactive protein. Patient-reported outcomes included the Inflammatory Bowel Disease Control Questionnaire (IBDCQ) and EQ-5D-5L quality-of-life scale, and psychosocial variables were assessed with validated health anxiety and medication belief instruments.

Results showed no significant differences in objective disease activity or biomarkers before and after the switch. Patient-reported symptoms measured by the IBDCQ improved slightly, from 13.3 before switching to 12.5 afterward (P = .043), though this change was small and of uncertain clinical importance. Quality-of-life measures did not meaningfully change.

Adverse events were reported by 25% of participants, with headaches, joint pain, nausea, fatigue, and injection site reactions among the most common. Importantly, statistical analysis indicated that health anxiety was a strong predictor of adverse event reporting, with each one-point increase in health anxiety score raising the likelihood of an event by 21% (P = .0079). Only 2 patients reverted to Humira because of intolerance.

Cost analysis revealed meaningful financial benefits. Switching reduced drug expenditures by €143,958 over 8 weeks for the cohort, amounting to an estimated €864,000 in annual savings. Even after accounting for switching clinic costs (€133 per patient) and unscheduled care needs, net savings averaged €2091 per patient over 2 months.

The authors noted that the structured switching clinic was resource-intensive but effective in minimizing uncertainty and ensuring patients received adequate support. They suggested that scaling such clinics could further reduce per-patient costs and improve uptake.

Study limitations included its single-center design, short follow-up period, and open-label structure, which prevented a definitive distinction between true adverse effects and nocebo responses. The lack of blinded comparators and the potential influence of the COVID-19 pandemic on response rates were also acknowledged.

Still, the results reinforce international evidence supporting biosimilar adalimumab as a safe and effective alternative to the reference product. “With biosimilar switching, prescribers may expect some patients to develop new side effects, particularly those with high levels of health anxiety,” the authors wrote.

Overall, the study demonstrated that a nonmedical switch to Amgevita preserved disease control and quality of life while delivering significant cost savings, highlighting the importance of patient education and structured implementation to address psychological factors and optimize outcomes.

References

1. Rabbitt L, Keogh Á, Duane L, et al. A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease. Br J Clin Pharmacol. 2025;91(9):2628-2635. doi:10.1002/bcp.70086

2. Jeremias S. 13 strategies to avoid the nocebo effect during biosimilar switching. The Center for Biosimilars^®. December 18, 2024. Accessed September 8, 2025. https://www.centerforbiosimilars.com/view/13-strategies-to-avoid-the-nocebo-effect-during-biosimilar-switching