Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars

Abstract

Anti-IFX antibodies of Remicade-treated patients cross-react with either Inflectra or Remsima. Although additional epitopes may be present in the biosimilar, results suggest that epitopes influencing the immune response to IFX are also present in the biosimilar. Antibody-positive patients treated with Remicade should not be switched to the biosimilar, since antibodies will interact with the new drug and potentially lead to loss of response. This finding supports the utility for therapeutic drug monitoring before a switching strategy is considered.

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

“…It is important to note, however, that this scenario is very different from switching between an originator biologic and its biosimilar or between different biosimilars of the same biologic: for example, two originator biologics targeting a given molecule may bind different epitopes, whereas a biologic and its biosimilar or two biosimilars of the same biologic should bind the same epitope. This difference probably explains why ADAs to infliximab demonstrate identical reactivity towards its biosimilar, whereas ADAs to adalimumab do not cross-react with infliximab or its biosimilar [114]. …”

Rapid loss of efficacy of biosimilar infliximab in three patients with Behçet’s disease after switching from infliximab originator

“…In the absence of a valid explanation, we could only hypothesize that the rapid failure of bio-IFX in our 3 patients might be related to the development of ADAs against re-IFX. In our clinical practice, we do not examine circulating ADAs and drug serum levels in patients receiving re-IFX, but the hypothesis of ADA-induced loss of efficacy for bio-IFX seems to be confirmed by a recent paper showing cross-reactivity of anti-re-IFX antibodies and bio-IFX (14). The higher proportion of antibody molecules with truncated C-terminal lysines, the differences in site-specific deamination, the lower level of afucosylated glycans, and other minor molecular and pharmacological differences of bio-IFX found in the EMA comparability exercise [6] may enhance the neutralizing action of antire-IFX antibodies in patients switched to the biosimilar drug.…”

Therapeutic Antibody‐Based Drugs in the Treatment of Human Inflammatory Disorders

“…Furthermore, initial studies also suggest that it is safe to switch to a biosimilar drug in anti-drug antibodynaïve patient [107]. However, a recent study has demonstrated that virtually all patients who developed anti-infliximab antibodies react to both inflectra and remsima-the infliximab biosimilar mAbs [108]. This suggests that epitopes that are present in infliximab that elicit the drug-specific antibodies are also present in the biosimilar mAbs [108].…”

“…However, a recent study has demonstrated that virtually all patients who developed anti-infliximab antibodies react to both inflectra and remsima-the infliximab biosimilar mAbs [108]. This suggests that epitopes that are present in infliximab that elicit the drug-specific antibodies are also present in the biosimilar mAbs [108]. It is also possible that new epitopes are present in the biosimilar, and, similarly, that unique drug epitopes can be present in the reference product.…”