Background: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have
revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of
their complexity, their production is expensive contributing to their high price. As the patent
protection of these therapies has expired in several countries, biosimilars have been developed
to reduce the healthcare costs. The aim of this article is to review the literature on the
safety, efficacy and immunogenicity of biosimilars in IBD.
Methods: A PubMed literature search was performed using the following terms until May
2016: ‘biosimilars’, ‘CT-P13’, ‘infliximab’, ‘Crohn’s disease’, ‘ulcerative colitis’, ‘inflammatory
bowel diseases’, ‘efficacy’, ‘safety’, ‘immunogenicity’. Additionally, abstracts from international
meetings were also reviewed.
Results: A total of eleven studies in IBD patients provided real-world evidence on the efficacy,
safety and immunogenicity profile of biosimilars in IBD patients. Based on the available
evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting.
The vast majority of studies only included IBD patients who had never received biological
therapies. Information regarding the interchangeability between CT-P13 and its originator is
currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile
of CT-P13 seems to be similar to the originator.
Conclusion: The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity
profile as the originator in IBD. Large prospective post-marketing studies are
needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars
may lead to major healthcare cost savings.