Experience with Biosimilar Infliximab (Remsima®) in Norway

Area of Science:

• Immunology
• Gastroenterology
• Pharmacology

Background:

• Remsima® (CT-P13) is the first approved monoclonal antibody biosimilar, a tumour necrosis factor-alpha inhibitor.
• While approved for all indications of originator infliximab (Remicade®), clinical efficacy is established mainly in rheumatic diseases.
• Remsima® is widely used in Norway for biologic-naïve inflammatory bowel disease (IBD) patients, raising concerns about indication extrapolation and product switching.

Purpose of the Study:

• To evaluate the efficacy, tolerability, and safety of Remsima® in IBD patients.
• To assess the impact of switching from Remicade® to Remsima® in IBD patients on maintenance therapy.

Main Methods:

• Prospective observational study of moderate to severe IBD patients treated with Remsima®.
• Observational study involving switching IBD patients from Remicade® to Remsima® maintenance therapy.

Main Results:

• Significant reduction in disease activity indices (Harvey Bradshaw for CD, partial Mayo and SCCAI for UC) and inflammatory markers (fecal calprotectin, CRP) after 14 weeks of Remsima® treatment.
• No significant changes in disease activity indices, CRP, or calprotectin were observed after switching from Remicade® to Remsima®.
• A significant increase in infliximab trough levels was noted in Crohn's disease patients post-switch, with no unexpected adverse events.

Conclusions:

• Remsima® appears efficacious and well-tolerated in IBD patients.
• The use of Remsima® has led to significant cost savings in healthcare.
• Further data, including from the NOR-SWITCH study, are expected to clarify the role of biosimilars in IBD and other immune-mediated inflammatory diseases.