Progress with infliximab biosimilars for inflammatory bowel disease

ABSTRACT

Introduction: Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected. Biosimilars represent less expensive alternatives compared to the reference product.

Areas covered: In this review, authors will review the literature on the clinical efficacy, safety and immunogenicity of current and future biosimilar infliximabs. Short- and medium-term data from real-life cohorts and from randomized-clinical trials in IBD demonstrated similar outcomes in terms of efficacy, safety and immunogenicity as the reference product for CT-P13. Switch data from the reference to the biosimilar product are also accumulating (including the NOR-SWITCH and the CT-P13 3.4 study).

Expert opinion: The use of biosimilar infliximab in IBD is increasing worldwide. Its use may be associated with budget savings leading to better access to biological therapies and consequently improved health outcomes. Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.

KEYWORDS:

• Infliximab
• biological therapy
• anti-TNF
• CT-P13
• biosimilar
• inflammatory bowel disease
• ulcerative colitis
• Crohn’s disease

Article highlights

1. Biological therapy has revolutionized the treatment of inflammatory bowel diseases, but their use is associated with significant increase in the direct drug-related medical costs in IBD and access to biological agents varies among countries.

2. The introduction of biosimilars could lead to considerable cost savings and better access to biologicals parallel with similar clinical efficacy and safety parameters.

3. Multiple biosimilars of IFX and ADA are in development and expected to enter the market in the coming years.

4. Non-medical switch and interchangeability represent challenges both for patients and clinicians.

This box summarizes key points contained in the article.

Declaration of interest

PL Lakatos has received honoraria from Celltrion, Pfizer Inc., Roche and Genentech. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper is not funded.