Expert Review of Gastroenterology & Hepatology (09/22/2015) Ben-Horin, Shomron; Heap, Graham A.; Ahmad, Tariq

Although biologics can be revolutionary treatments, potential immune responses to the drugs can limit their clinical efficacy and safety. The European Medicines Agency (EMA) recently approved CT-P13 (Remsima, Inflectra), a biosimilar of the monoclonal antibody infliximab (Remicade), which is used for several immune-mediated inflammatory disorders. CT-P13 is approved for all indications in which infliximab is approved. This approval was based partly on extrapolation of clinical trial data from rheumatoid arthritis (RA) and ankylosing spondylitis (AS) to other indications, such as inflammatory bowel disease. EMA extrapolates immunogenicity data across indications as part of its biosimilar approval process. There are concerns about the extrapolation of data to other indications, especially regarding immunogenicity, because anti-drug antibody (ADA) formation is unpredictable and can vary between indications. However, a review of data shows no noticeable differences in immunogenicity between infliximab and CT-P13, and extrapolation of immunogenicity data for CT-P13 collected in RA and AS to other indications appears clinically valid, researchers report.

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