FDA/CDC

FDA approves infliximab biosimilar Ixifi for all of Remicade’s indications


 

The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.

Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

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Approval for Ixifi is based on the totality of analytic, pharmacologic, and clinical evidence submitted by Pfizer, including results from the REFLECTIONS B537-02 study, a phase 3 clinical trial that compared infliximab-qbtx to Remicade in patients with moderate to severe rheumatoid arthritis. Both drugs had a similar proportion of patients meet the study endpoint goal of a 20% reduction in American College of Rheumatology criteria after 14 weeks.

The most common adverse events associated with Ixifi are upper respiratory infections, sinusitis, pharyngitis, infusion-related reactions, headache, and abdominal pain.

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