European Data Confirms Real-World Benefits of Adalimumab Biosimilars

In response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and the UK offer compelling insights into the practical benefits of ABP 501 (Amgevita/Amjevita), a leading adalimumab biosimilar.¹

New research highlights the effectiveness and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases. | Image credit: garrykillian - stock.adobe.com

The treatment of debilitating immune-mediated inflammatory diseases (IMIDs) like rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis (PsO) has seen a dramatic shift with the introduction of adalimumab biosimilars.

The study, published in Rheumatology and Therapy, involving 1296 patients who either started on ABP 501 or switched from the reference product (Humira), directly tackled critical questions about its real-world effectiveness, patient satisfaction, and impact on daily life.

The data emphatically demonstrated that ABP 501 delivered positive treatment outcomes, earning high satisfaction marks from both patients and their treating physicians, regardless of prior exposure to the reference product. Physicians reported overwhelming satisfaction with disease control provided by ABP 501. Among patients who initiated ABP 501 as their first advanced therapy, physician satisfaction rates exceeded 89% across all disease cohorts, even reaching more than 95% in AS, PsA, and PsO.

For those initiating ABP 501, a significant majority of patients across all IMIDs were assessed by their physicians as having mild disease at the time of consultation—ranging from 63.2% in AS to an impressive 83.0% in PsO after a median of 10.4 to 12.3 months on the biosimilar. Pain levels also showed remarkable improvement, with a large proportion of patients experiencing mild or no pain.

Patients echoed their physicians' positive assessments. A substantial majority of ABP 501 initiators, more than 86% across all indications, reported high satisfaction with their treatment regimen. Importantly, their health-related quality of life (HRQOL) measures consistently indicated minimal disease impact on their daily lives. Low scores for work productivity and activity impairment further emphasized the biosimilar's positive effect on patients' ability to participate in daily activities and work.

The study also shed light on the experiences of patients who transitioned from the reference product to ABP 501. The drivers for these switches were often pragmatic, with physicians citing formulary-driven switches, financial considerations, and insurance restrictions as primary reasons. Crucially, these non-clinical motivations did not translate into compromised patient care or satisfaction. Both physicians and patients maintained high satisfaction levels with ABP 501 after the switch, exceeding 93% for physicians and at least 94.7% for patients across indications. Moreover, patient-reported HRQOL remained strong following the switch, demonstrating a seamless transition without any discernible negative impact on patient well-being or treatment efficacy. This finding is particularly significant for managed care organizations, as it helps to alleviate concerns about potential "nocebo effects" sometimes associated with biosimilar transitions.

This robust real-world evidence provides compelling arguments for managed care organizations to fully embrace adalimumab biosimilars like ABP 501. Driven by financial and administrative advantages, these biosimilars offer a significant opportunity to reduce health care expenditures for IMID management, leading to more efficient resource allocation and benefiting a broader patient population.

The high satisfaction among both physicians and patients, coupled with positive clinical outcomes, should bolster confidence in prescribing biosimilars, especially for extrapolated indications. The sustained high HRQOL and satisfaction reported by patients after switching underscore that biosimilars maintain positive patient experiences and promote adherence.

Another real-world analysis focusing on nonmedical switching from the adalimumab originator to adalimumab biosimilars revealed that patient-reported outcomes were maintained post-switch, showing the continued safety and efficacy for patients with chronic inflammatory conditions.²

The authors of the present study concluded, “Our findings add to the growing body of real-world experience with biosimilar use which help address barriers to utilization due to lack of awareness and concerns about inadequate efficacy from both patients and physicians, especially for indications approved on the principle of extrapolation and for patients who switch from the reference product.”¹

References

1. Jin R, Haughton JM, Goddard EJ, et al. Real-world experience with an adalimumab biosimilar (ABP 501) in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis in Europe: results from the Adelphi Disease Specific Programme. Rheumatol Ther. 2025;12(3):469-492. doi:10.1007/s40744-025-00755-9

2. Jeremias S. Study on nonmedical switching for adalimumab biosimilars warns about nocebo effect. The Center for Biosimilars^®. April 27, 2023. Accessed June 2, 2025. https://www.centerforbiosimilars.com/view/study-on-nonmedical-switching-for-adalimumab-biosimilars-warns-about-nocebo-effect