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Expert Review of Clinical Immunology (02/16) Fiorino, Gionata; Fazio, Maria; Danese, Silvio

Biosimilars offer the opportunity to treat patients with inflammatory bowel disease (IBD) at a greatly reduced cost. Preliminary observations show that the infliximab biosimilar may not differ from the originator in regard to efficacy, safety, and immunogenicity. In fact, not only did recent real-life cohort studies from different countries support the bioequivalence of infliximab biosimilars in IBD, but all available data support the fact that there is no clinically meaningful structural difference between the two molecules. Studies also showed no concerns about safety or immunogenicity. Long-term data is still essential, however, and while current knowledge supports the use of biosimilars in all patients naïve to infliximab, more long-term data may be needed to support this approach in all patients. The key advantage in the use of biosimilars is the expected cost saving on health-care resources. Despite this benefit, a primary concern from IBD specialists and patients is about immunogenicity, which could impact the interchangeability between the originator and biosimilars.

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