The Growing Impact of Biosimilars in IBD Care

Biosimilars have been proven to be a cost-effective alternative to biologics in the management of inflammatory bowel disease (IBD), offering comparable efficacy and safety while reducing financial burden, according to a review published in Clinical and Experimental Medicine.1

This review was conducted to address the growing global burden of IBD, an umbrella term for Crohn disease and ulcerative colitis, which affects about 7 million people globally, and the financial challenges associated with biologic treatments.1,2 As IBD prevalence rises and demand for effective therapies increases, the high cost of biologics limits access, especially in low- and middle-income countries.

Biosimilars have emerged as cost-effective alternatives with similar efficacy and safety, but concerns about adverse effects remain. The review explores the potential of advanced drug delivery systems (DDSs) to overcome these limitations, improve treatment outcomes, and make IBD care more accessible and effective worldwide.

This study, part of the Global Burden of Disease (GBD) 2017 project, assessed the global impact of Crohn disease and ulcerative colitis. Mortality estimates used vital registration and verbal autopsy data, modeled with the Cause of Death Ensemble model and adjusted to align with overall mortality rates. Nonfatal estimates were based on literature, hospital records, and US claims data, analyzed using the DisMod-MR 2.1 Bayesian tool to ensure consistency across disease metrics. Adjustments accounted for indeterminate colitis cases.

The burden of disease was measured using prevalence, years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs) across 195 countries. Estimates were age-standardized and included 95% uncertainty intervals. The funder had no role in the study’s design, analysis, or reporting.

The pathophysiology of IBD involves genetic, environmental, microbiome, and immune system factors. Over 240 genetic loci linked to IBD were identified, highlighting its polygenic nature. Environmental changes, including industrialization, disrupt the gut microbiome, triggering inflammation in a weakened intestinal barrier. An imbalance between regulatory and effector T cells fuels immune activation.

IBD therapies include biologics and small molecules targeting inflammatory pathways. Anti-TNF-α agents (eg, infliximab, adalimumab) and their biosimilars are approved. Integrin blockers like vedolizumab and IL-12/23 inhibitors (eg, ustekinumab) reduce inflammation. Janus kinase inhibitors (eg, tofacitinib) offer fast-acting oral options, though safety concerns persist. Ozanimod, an sphingosine-1-phosphate receptor modulator, limits lymphocyte trafficking in ulcerative colitis.

Biologic development is complex, with small manufacturing changes affecting stability and efficacy, increasing immunogenic risks such as antidrug antibodies, infusion reactions, hypersensitivity, and neutralization of therapeutic antibodies. Therapeutic drug monitoring may help manage these risks.

Safety concerns include infection reactivation (tuberculosis), hypersensitivity, autoimmunity, and malignancies, such as lymphoma. Clinicians should screen patients, ensure vaccinations, and monitor throughout treatment.

Innovative drug delivery systems are improving biologic and biosimilar use in IBD by enhancing targeting, reducing adverse effects, and improving patient experience. Strategies like passive targeting nanoparticles or mucoadhesive systems, as well as active targeting ligands for CD44 or folate receptors, show strong potential for safer, more effective therapies.

The authors concluded with recommendations for future research in this area. “Research should prioritize innovative solutions that address issues such as protection from enzymatic degradation, enhancement of mucosal penetration, improvement of site-specific drug delivery, and minimizing systemic drug exposure,” they wrote. “Addressing these challenges holds the key to unlocking the full therapeutic potential of nanoparticle-based DDSs in the management of IBD and other complex diseases.”

References

1. Aljabri A, Soliman GM, Hetta HF, et al. Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems. Clin Exp Med. Published online April 5, 2025. doi:10.1007/s10238-025-01558-6

2. GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17-30. doi:10.1016/S2468-1253(19)30333-4