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Updated: Apr 3, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?
Shomron Ben-Horin1, Graham A Heap2,3, Tariq Ahmad2,4
1a 1Gastroenterology Department, Sheba Medical Center and Sackler School of Medicine, Tel-Aviv University, Tel Hashomer, Israel.
Abstract:
Biopharmaceuticals or 'biologics' have revolutionized the treatment of many diseases. However, some patients generate an immune response to such drugs, potentially limiting clinical efficacy and safety. Infliximab (Remicade(®)) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders. A biosimilar of infliximab, CT-P13 (Remsima(®), Inflectra(®)), has recently been approved in Europe for all indications in which infliximab is approved. Approval of CT-P13 was based in part on extrapolation of clinical trial data from two indications (rheumatoid arthritis and ankylosing spondylitis) to all other indications, including inflammatory bowel disease. This review discusses the validity of extrapolating immunogenicity data across indications - a process adopted by the EMA as part of their biosimilar approval process - with a focus on CT-P13.
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