Data on nonmedical switching from one anti-Tumor Necrosis Factor (TNF)-α biosimilar to another in inflammatory bowel disease (IBD) are relatively sparse. We aimed to study the effects of nonmedical switch from infliximab biosimilar CT-P13 to SB2 and from adalimumab biosimilar ABP 501 to SB5.

In this observational study, consecutive IBD patients receiving nonmedical switch were prospectively followed-up for 12 months. The primary outcome was treatment persistence; other outcomes included: secondary effectiveness outcomes, safety, immunogenicity, inflammatory makers levels and psychometric assessments.

A total of 119 and 76 patients were enrolled in the SB2 and SB5 cohorts. Persistence on treatment at 12 months was 84.0 % in the SB2 cohort and 78.9 % in the SB5 cohort. No clinically meaningful changes in other secondary effectiveness outcomes were recorded. Rates of 0.38 and 0.63 adverse events of interest per 100 patient-years were observed in the SB2 and SB5 cohorts. The pharmacokinetics and immunogenicity of either drug were unaffected by nonmedical switch; similarly, levels of inflammatory cytokines remained largely unchanged. No changes in psychometric assessments were recorded.

Nonmedical switch of infliximab and adalimumab biosimilars does not significantly affect treatment effectiveness, safety and pharmacokinetics, nor does it have major psychological implications for patients.

Over the last decade, the treatment options for inflammatory bowel disease (IBD) have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate inflammation. Adalimumab (ADA) is a tumor necrosis factor alpha antagonist and stands as an effective treatment for IBD. In April 2021, the province of British Columbia implemented a mandatory non-medical switch policy of the ADA originator Humira® to ADA biosimilars. Biosimilars offer a potential cost-effective, safe, and efficacious alternative to the originator, yet there remains limited real-world evidence on long-term outcomes of ADA non-medical switching in IBD.

To assess the long-term outcomes of non-medical switching from the ADA originator Humira® to an ADA biosimilar among IBD patients.

A retrospective observational chart review study was conducted on IBD patients eligible for the provincially mandated non-medical switch to an ADA biosimilar. The primary outcome was treatment persistence at 30 months post-switch. Secondary outcomes included the proportion of and reasons for therapy alteration or ADA discontinuation, loss of response (LOR) rates, adverse events (AE), and clinical and biochemical remission status. Patients who remained on the originator throughout the switch period, through compassionate support or private pay, constituted the comparison group.

Patients in the originator (n = 43) and biosimilar switch (n = 228) groups displayed similar demographics and baseline disease characteristics. By the study endpoint of 30 months, there was no difference in the rate of treatment persistence in either group (n = 36, 83.7% originator group vs n = 201, 88.2% biosimilar group, P = 0.451). Treatment persistence demonstrated similar rates of discontinuation between both study groups (log-rank P = 0.543). There was a numerical but not statistically significant difference in rates of adverse outcomes between either group (39.5% originator vs 28.9% biosimilars, P = 0.206). This included comparable rates of LOR (27.9% vs 17.5%) or AE (11.6% vs 11.4%) between the originator and biosimilar cohorts, respectively. C-reactive protein and fecal calprotectin levels were similar one year pre- and post-switch.

These data support the long-term efficacy and safety of non-medical ADA switching in IBD and will help inform patients and physicians in jurisdictions currently undergoing biosimilar switching.

Inflammatory bowel diseases (IBD) currently impose an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in an unavoidable lifetime expense. The introduction of infliximab more than two decades ago had revolutionized IBD treatment. Nowadays, while biologic drugs comprise various vital therapeutic options for patients, they can be associated to significant costs to healthcare systems. The most crucial benefit of biosimilars is that they bring more significant cost reduction and increase access to advanced therapies. They also allow the treatment of newly diagnosed patients and dose optimization for those who need it. There is an inverse relationship between price and demand for treatment with biologics. For a more significant reduction in cost to be possible, greater use of biosimilars is necessary. For this to occur, it is imperative not only to use biosimilars in naïve patients but also to switch to biosimilars in those patients who have started therapy with reference biologics. At present, randomized and observational studies have demonstrated effectiveness and safety results in recommending a single switch between a reference product and a biosimilar, and vice versa. The purpose of this manuscript is to review the literature and discuss whether scientific evidence is enough to support multiple switches of biologics and biosimilars in IBD patients.

Annual out-of-pocket expenditures for patients with inflammatory bowel disease (IBD) are estimated to be as high as $41,000, with medications, such as biologics, being one of the main cost contributors. Although biologics have revolutionized IBD management, these medications are costly owing to their molecular makeup and manufacturing processes. Biosimilars, which are biologic medications that are highly similar to the US Food and Drug Administration (FDA)-approved reference product with no clinically meaningful differences in safety, purity, or potency, offer the same therapeutic benefits at a reduced cost. Other additional benefits offered with biosimilars include increased treatment access and fostered development of new therapeutic options. Despite the expansion of biosimilars in IBD, their adoption and utilization have been suboptimal in the United States. This article provides an overview of the biosimilar landscape in IBD, including FDA-approved biosimilars available, and a clinical guide to navigate switching to biosimilars in various clinical scenarios based on current evidence.

As of 31 December, 2023, 31 observational studies have been published, including a total of 6081 patients who underwent a switch from one biosimilar to another biosimilar of the same reference biologic. Most studies evaluated infliximab, while a smaller number evaluated adalimumab, rituximab or etanercept. Indications studied now include sarcoidosis, as well as the indications previously reported of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis/ankylosing spondylitis and inflammatory bowel disease (Crohn's disease and ulcerative colitis). This updated data set includes eight additional studies and 2386 more patients compared with those included in an earlier systematic review of biosimilar-to-biosimilar switching. In addition, since the earlier systematic review was published in 2022, the European Medicines Agency has stated that reference-to-biosimilar and biosimilar-to-biosimilar switching in the European Union is safe and efficacy remains unchanged after switching. Furthermore, following a review of the available evidence, the US Food and Drug Administration has confirmed that initial safety and immunogenicity concerns related to biosimilar switching are unfounded and that no differences are observed in efficacy, safety or immunogenicity following one or more switches. The availability of this new efficacy and safety data together with the supportive statements from the European Medicines Agency and the Food and Drug Administration re-confirm the conclusion that as a scientific matter, biosimilar-to-biosimilar switching is an effective clinical practice, with no new safety concerns. Any suggestions to the contrary are not supported by the evidence.