Biosimilar switching not suitable for all patients

Switching to biosimilars may not be suitable in around half of patients who have already developed antibodies against the originator drug, according to study findings.

The results published at the European League Against Rheumatism annual conference (EULAR 2016) showed that when antibodies develop in response to treatment with Johnson & Johnson/MSD’s Remicade (infliximab) inflammatory diseases drug, they also cross-react with Celltrion’s Remsima/Inflectra biosimilar infliximab.

Findings of the study, which has been peer-reviewed and was not funded by a pharma company, suggest that antibody-positive patients treated with Remicade should not be switched to treatment with the biosimilar, since the antibodies will interact with the new drug and potentially lead to loss of response.

The biosimilar is a near-copy of Remicade manufactured by the South Korean company but marketed in Europe by Hospira as Inflectra and Mundipharma and others as Remsima.

The study included 250 rheumatoid arthritis and spondyloarthritis patients undergoing Remicade treatment who had never previously been treated with the biosimilar, and 77 control patients.

Using assays to assess concentrations of anti-infliximab antibodies, 50.4% of Remicade-treated patients tested positive for anti-infliximab antibodies, and 100% of those who tested positive for anti-infliximab antibodies also exhibited antibody reactivity against the biosimilar.

Results are aligned with previous antibody data among patients with inflammatory bowel disease being treated with Remicade. Further studies are planned with biosimilar-treated patients to better assess the potentially different immune responses associated with biologics.

Lead author, Dr Daniel Nagore of Spain-based molecular testing firm Progenika Biopharma, said: “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.”

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