The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?

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Authors
Ben-Horin, S.
Heap, Graham A.
Ahmad, Tariq
Kim, H.
Kwon, T.
Chowers, Y.
Journal
Expert review of gastroenterology & hepatology
Type
Journal Article
Publisher
Taylor & Francis
Rights
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((R))) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders. A biosimilar of infliximab, CT-P13 (Remsima((R)), Inflectra((R))), 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.
Citation
Expert Rev Gastroenterol Hepatol. 2015 Sep;9 Suppl 1:27-34
Note