Biosimilars in Inflammatory Bowel Disease - Accumulating Clinical Evidence

ABSTRACT

Introduction: Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn’s disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states. Clinicians use these products with caution secondary to lack of clinical experience.

Areas Covered: The authors performed a literature search using the following keywords: CT-P13, biosimilar, adalimumab, infliximab, ABP 501, and inflammatory bowel disease. Bibliographies were also reviewed for pertinent articles. Articles pertaining to the clinical efficacy of biosimilars in IBD were included.

Expert commentary: The phase 3 trials, which provided the clinical justification to bring TNF- α biosimilars to market, were in rheumatoid arthritis and ankylosing spondylitis; however, new clinical data suggests that biosimilar products have equivalent safety and efficacy to reference products in IBD. This has led to an increased acceptance amongst practicing gastroenterologists and a potential reduction in healthcare costs.

KEYWORDS:

• ABP-501
• adalimumab
• biosimilar
• CT-P13
• indication extrapolation
• infliximab

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded.