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

Shomron Ben-Horin*, Graham A. Heap, Tariq Ahmad, Ho Ung Kim, Taek Sang Kwon, Yehuda Chowers

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Pages (from-to)27-34
Number of pages8
JournalExpert Review of Gastroenterology and Hepatology
StatePublished - 28 Sep 2015


FundersFunder number
Aspire Scientific Limited
Celltrion Healthcare Co., Ltd


    • CT-P13
    • biologics
    • biosimilars
    • extrapolation
    • immunogenicity
    • inflammatory bowel disease, infliximab


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