title: The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?
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.
authors.affiliation: a 1Gastroenterology Department, Sheba Medical Center and Sackler School of Medicine, Tel-Aviv University, Tel Hashomer, Israel.
authors.forename: Shomron
authors.initials: S
authors.lastname: Ben-Horin
authors.affiliation: b 2 Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.|c 3 IBD Pharmacogenetics, University of Exeter, Exeter, UK.
authors.forename: Graham A
authors.initials: GA
authors.lastname: Heap
authors.affiliation: b 2 Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.|d 4 University of Exeter, Exeter, UK.
authors.forename: Tariq
authors.initials: T
authors.lastname: Ahmad
authors.affiliation: e 5 Celltrion, Incheon, Republic of Korea.
authors.forename: HoUng
authors.initials: H
authors.lastname: Kim
authors.affiliation: e 5 Celltrion, Incheon, Republic of Korea.
authors.forename: TaekSang
authors.initials: T
authors.lastname: Kwon
authors.affiliation: f 6 Gastroenterology Department, Rambam Health Care Campus & Bruce Rappaport School of Medicine, Technion Israel Institute of Technology, Haifa, Israel.
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Chowers
mesh_terms: D000818:Animals; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D000069285:Infliximab / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: CT-P13; biologics; biosimilars; extrapolation; immunogenicity; inflammatory bowel disease; infliximab