The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

Abstract

The over-production of TNF-α can lead to chronic inflammation and organ damage in immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), axial spondyloarthritis, psoriasis, and inflammatory bowel disease (IBD). Anti-TNF therapy is generally considered to be an effective, well-tolerated treatment option for the management of chronic inflammation in these conditions. Over the past decade, patents for the original reference anti-TNF agents have expired, permitting the development of anti-TNF products that are biologically similar, termed ‘biosimilar’, to the original reference product. Differences in the approval process mean that biosimilars are often available to healthcare services at a considerably lower cost compared with the reference products, providing an opportunity to improve patient access to the benefits of anti-TNF therapy. However, despite the spreading use of biosimilars across healthcare services, some clinicians remain reluctant to prescribe them. The gradual accumulation of long-term data on the real-world use of biosimilars, and an improved understanding of the development and approval process for these products, may help to increase clinicians’ confidence to increase usage of biosimilars. This mini review summarises the current status of anti-TNF biosimilars in clinical practice, including the requirements for regulatory approval, real-word evidence for their equivalence to novel anti-TNFs, guidelines for their use, and challenges to their acceptance by both clinicians and patients.