Non-Medical Switch to Infliximab Biosimilar Demonstrates Similar Outcomes for IBD

The non-medical biosimilar switch of infliximab (Remicade; Janssen Immunology) showed similar outcomes when compared to the reference product for the treatment of inflammatory bowel disease (IBD). The data demonstrate the safety and efficacy of non-medical switching for the patient population.¹

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IBD includes Crohn disease (CD) and ulcerative colitis (UC), both of which are chronic and can be debilitating. Biologics have changed the landscape of therapy, but cost has impacted the uptake of the medications in health care. Biosimilars often benefit patients through affordability and accessibility improvements while providing comparable safety and efficacy to the reference products. In Canada, there is a nationwide mandatory biosimilar switch policy, which most provinces have adopted. In October 2023, researchers conducted a systematic review of real-world data regarding infliximab and adalimumab biosimilars. Results were comparable between patients at 12 months, although infliximab was only recommended for treatment-naïve patients despite low quality of evidence.^2,3

In the new analysis, investigators obtained real-world evidence to evaluate the clinical outcomes of non-medical switching from the reference product to biosimilars (CT-P13 [Inflectra; Pfizer) or SB2 [Samsung Bioepis]). Investigators specifically determined the frequency of treatment persistence, adverse effects, loss of response, and immunogenicity following the mandated switch, according to the study authors.¹

The single-center, retrospective, observational study included electronic medical records between January 1, 2006, and October 1, 2021. Individuals were included if they were 18 years or older with a diagnosis of CD or UC. Patients also previously received the reference product and were switched to the biosimilar between September 5, 2019, and March 5, 2020.¹

The primary outcome was treatment continuation at 12 months post-switch in the biosimilar group, and secondary outcomes included reason for discontinuation—loss of response, adverse events or patient factors. Dosage changes, therapeutic drug monitoring levels, and immunogenicity were also recorded, as well as patient demographics.¹

There were 265 patients who underwent the non-medical biosimilar switch during the study period, and 99 continued the reference product. Approximately two-thirds of the patients had CD and one-third had UC. Approximately 41% switched to CT-P13 and the remainder transitioned to SB2. The median duration of continuation post-switch was approximately 18 months during the first 12 months of follow up and there were no statistically significant differences in frequency of treatment continuation, according to the study authors. Of those who remained on infliximab at 1 year (90.1%), 69.9% and 20.1% had CD and UC, respectively, compared with 91.7% and 86.7%, respectively, in the switch cohorts.¹

All cause treatment discontinuations demonstrated no significant differences post-switch, with 9.81% in the biosimilar group and 6.06% in the reference group. Additionally, there were no differences between either biosimilar used or the reference product. In the biosimilar group, 13 patients stopped treatment due to loss of response compared with 4 in the reference product group. Eight individuals in the biosimilar group discontinued due to adverse events with 1 adverse event leading to discontinuation in the reference product group, according to the study authors.¹

REFERENCES

1. Hoang TT, Reid J, Galorport C, Bressler B, Leung Y, Rosenfeld G. Outcomes of a mandatory non-medical switch of infliximab to a biosimilar for inflammatory bowel disease in British Columbia, Canada. J Can Assoc Gastroenterol. 2024;7(4):299-305. Published 2024 Mar 23. doi:10.1093/jcag/gwae011

2. McGovern G. No Significant Differences in Efficacy Shown Between Reference Drug, Biosimilars in Patients With IBD. Pharmacy Times. January 18, 2024. Accessed September 9, 2024. https://www.pharmacytimes.com/view/no-significant-differences-in-efficacy-shown-between-reference-drug-biosimilars-in-patients-with-ibd

3. Miller S. Real-World Evidence Enters the Discussion for Biosimilar Switching. Pharmacy Times. February 23, 2024. Accessed September 9, 2024. https://www.pharmacytimes.com/view/real-world-evidence-enters-the-discussion-for-biosimilar-switching