100% of patients?who developed antibodies to?innovator anti-TNF-? exhibited antibody reactivity against the biosimilar. ?Study results cast?doubt on interchangeability.

8 June 2016
According to a report from European League Against Rheumatism Annual Congress (EULAR) 2016, patients with antibodies to biological infliximab are less likely to benefit from infliximab biosimilar (CT-P13). Abstract OP0015 presents the study results demonstrating that when antibodies develop in response to the biological treatment with the innovator product,?infliximab, they also cross-react with the biosimilar of infliximab (CT-P13). These findings suggest that antibody-positive patients being treated with infliximab should not be switched to treatment with the biosimilar, since their results show that the?antibodies will interact with the new drug (i.e., the biosimilar) and potentially lead to a loss of response.

The study included 250 biosimilar-naiive patients with rheumatoid arthritis and spondyloarthritis, plus?77 control patients.

?Our results have shown that all the antibodies that developed in patients being treated with Remicade cross-reacted with the biosimilar. The presence of these anti-infliximab antibodies is likely to enhance clearance of the drug from the body, potentially leading to a loss of response, as well as increasing the risk of side effects. Therefore, in patients where biological infliximab is ineffective due to the presence of circulating antibodies, switching to its biosimilar will lead to the same problems,? said lead author Dr Daniel Nagore of Progenika Biopharma, Derio, Spain.

Additional studies are planned.

Additional?Resources

FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say

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Update on Biosimilars US Regulation 1st Quarter 2016

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FDA releases draft biosimilar labeling guidance

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Biosimilars: Is It Safe to Switch?