Experience with Biosimilar Infliximab (Remsima®) in Norway

Abstract

Background: The first monoclonal antibody biosimilar to be used in clinical practice is the tumour necrosis factor-alpha inhibitor Remsima® (CT-P13). The drug is approved for all indications as the originator infliximab (Remicade®) although clinical efficacy has been demonstrated only in rheumatic diseases. Since the fall of 2013, Remsima® has been available in Norway and from January 2014, it has been the drug of choice when initiating biological treatment in biologics naïve patients with inflammatory bowel disease (IBD). However, many gastroenterologists have been greatly concerned about the extrapolation of indication. Switching between Remsima® and the innovator product is another issue that has been discussed. Key Messages: Good efficacy, tolerability and safety were demonstrated in a prospective observational study of IBD patients with moderate to severe disease activity. After 14 weeks of treatment there was a significant reduction in the Harvey Bradshaw index in patients with Crohns disease (CD) and reduction in the partial Mayo score and simple clinical colitis activity index in patients with ulcerative colitis. In both patient groups, there was also a significant reduction in fecal calprotectin and C-reactive protein (CRP). In another observational study, IBD patients on maintenance treatment with Remicade® were switched to Remsima®. By comparing values before and after switch, no changes in activity indices, CRP or calprotectin were observed. However, a significant increase in infliximab trough levels was shown in the CD group. No unexpected adverse events occurred after switching. Conclusions: Based on our experience in Norway, Remsima® seems to be efficacious and well tolerated in IBD. The increasing use of Remsima® in clinical practice has also contributed to significant cost savings on the health budget. Results from the NOR-SWITCH study will be available during 2016 and will hopefully contribute to answer some of the important questions that have been raised following the introduction of biosimilars as a treatment option for IBD and other immune-mediated inflammatory diseases.

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…In Scandinavian countries, biosimilar availability has heralded significant cost savings and expanded patient access to biologics, despite already high use [10,132]. In Norway, most patients with newly diagnosed IBD have received biosimilar infliximab since 2014, and, more recently, patients receiving infliximab maintenance therapy have switched to biosimilar infliximab [156]: following the introduction of infliximab biosimilars, patient access increased and expenditure reduced [132]. A mandatory switch to biosimilar infliximab for IBD induction and maintenance therapy has also been partially implemented in Norway, Poland, and the UK [157], and France aims to reach 80% biosimilar penetration by 2022, partly through switching RP-treated patients [158].…”

Looking to the future and learning lessons from the recent past: changing stakeholder perceptions of biosimilars in cancer

“…Overall, real-world evidence collected about IBD confirms that CT-P13 shows good efficacy and tolerability in patients with Crohn's disease or ulcerative colitis, whether these patients are infliximab naive or switched from treatment with reference infliximab [52][53][54][55][56]. Determining whether switching from reference infliximab to CT-P13 had any impact on the efficacy, safety or immunogenicity of treatment was the aim of a Phase IV, randomized controlled trial that was sponsored by the Norwegian government (the NOR-SWITCH study).…”

Adoption of Biosimilar Infliximab for Rheumatoid Arthritis, Ankylosing Spondylitis, and Inflammatory Bowel Diseases in the EU5: A Budget Impact Analysis Using a Delphi Panel

“…Physicians' price sensitivity is also related to national policies, which can stimulate the use of biosimilars in various ways. For instance, specific regulation is installed in Norway to increase the uptake of biosimilars, amongst which biosimilar infliximab, and reduce biosimilar prices substantially (Jahnsen and Kaasen Jorgensen, 2017). …”