Abstract
Infliximab is a chimeric recombinant therapeutic monoclonal ant ibody against the pro-inflammatory cytokine TNFα. Biosimilar in fliximab CT-P13 is biologically similar to the original infliximab, with a comparable pharmacodynamics and affinity to monomeric and trimeric forms of human TNFα.
However, even a minor molecular differences between CT-P13 from the original infliximab could be the reason for the possible different behavior of biosimilar molecule in the immunoanalytical detection systems. The objectives of this study were (a) to compare the serum levels of original and biosimilar infliximab by a routinely used enzyme immunoassay; and (b) to compare the incidence of antibodies to the original and biosimilar inflixmab as well as an induction of non- organ specific autoantibodies in patients with inflammatory bowel diseases (IBD).Dilution experiment was realized with pooled human serum from healthy blood donors with addition of original and biosimilar infliximab; for the detection of drug serum levels, enzyme immunoassay was used.
In a study of the incidence of antibodies to infliximab and induction of autoantibodies, sera of patients with IBD were used, namely 71 individuals treated with the original and 60 patients treated with the biosimilar infliximab. Sera were collected at the week zero (W0), second (W2) and fourteenth (W14) weeks of the treatment.