title: Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13).
abstract: Anti-drug antibodies against biologic drugs affect efficacy and safety; therefore, it is important to use appropriate assays for immunogenicity testing in clinical studies. This review describes the electrochemiluminescent (ECL) immunoassay, ELISA, radioimmunoassay, and homogeneous mobility shift assay. The characteristics of ECL, used to assess immunogenicity in comparison trials of CT-P13 (Remsima(®), Inflectra(®)) versus its reference medicinal product, infliximab (Remicade(®)), are also compared with the other assays, based on published literature. These comparisons show that ECL is more sensitive than ELISA, radioimmunoassay, and homogeneous mobility shift assay, and less affected by drug interference than ELISA. Similar immunogenicity was observed for CT-P13 and reference medicinal product using ECL, demonstrating the reliability of this method to assess immunogenicity in comparative studies.
authors.forename: Ji Soo
authors.initials: JS
authors.lastname: Kim
authors.affiliation: a Celltrion, 13-6, Songdo-dong, Yeonsu-gu, Incheon, Republic of Korea.
authors.forename: Sung Hwan
authors.initials: SH
authors.lastname: Kim
authors.affiliation: a Celltrion, 13-6, Songdo-dong, Yeonsu-gu, Incheon, Republic of Korea.
authors.forename: ByoungOh
authors.initials: B
authors.lastname: Kwon
authors.affiliation: a Celltrion, 13-6, Songdo-dong, Yeonsu-gu, Incheon, Republic of Korea.
authors.forename: SeungSuh
authors.initials: S
authors.lastname: Hong
mesh_terms: D000906:Antibodies / Q000276:immunology*; D000911:Antibodies, Monoclonal / Q000276:immunology*; D059451:Biosimilar Pharmaceuticals; D024202:Electrophoretic Mobility Shift Assay / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007118:Immunoassay / Q000379:methods; D000069285:Infliximab / Q000276:immunology*; D011863:Radioimmunoassay / Q000379:methods; D015203:Reproducibility of Results
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: CT-P13; ELISA; analytic methods; anti-drug antibodies; biosimilar; electrochemiluminescent assay; homogeneous mobility shift assay; immunoassays; infliximab; radioimmunoassay