Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity

Biosimilar products are now readily available for infliximab which is routinely used to treat rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and ankylosing spondylitis (AS) along with other conditions. This review aimed to summarise the available evidence on the clinical efficacy, safety profile, and immunogenicity of a biosimilar as compared to the reference product to address the concern of clinicians in switching from the reference product to a biosimilar. We searched PubMed, Embase, and Cochrane Library using the following terms: 'infliximab', 'biosimilar', 'reference product', AND 'switch'. Further relevant articles were identified through exploring the reference lists of the identified articles. Ten randomised clinical trials, enrolling 2308 patients, and 13 observational studies, enrolling 4453 patients, were identified. The results of these studies suggest that the efficacy of a biosimilar is comparable to that of the reference product in patients with RA, AS, and IBD. This study found that a biosimilar is well-tolerated and has a similar profile of safety as the reference product. The observational cohort studies involving patients switched from the reference product to a biosimilar reported comparable efficacy at maintaining disease remission. They also indicated stable disease activity and no considerable changes in the inflammatory markers after the switch. The evidence, which is ever-increasing, indicates that the use of a biosimilar is effective, well-tolerated, safe, and comparable in terms of immunogenicity, even in the long run. The availability of a biosimilar would ultimately improve patient access to treatment, and in turn, reduce the price of the reference drug.