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.

FDA icon
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.

Recommended Reading

For women with RA, small-joint surgery rate nearly twice that of men
MDedge Rheumatology
Study explores why RA patients discontinue methotrexate
MDedge Rheumatology
Expert discusses risks of biosimilars in rheumatology
MDedge Rheumatology
Biosimilars and sources show mostly parallel safety profiles
MDedge Rheumatology
Arthritis prevalence higher than previously thought, especially in adults under 65
MDedge Rheumatology
Novel oral orphan drug tames pemphigus
MDedge Rheumatology
Health disparities in rural America: Chronic conditions
MDedge Rheumatology
Early weight change has no special effect on mortality in RA
MDedge Rheumatology
Study supports methotrexate monotherapy with TNF inhibitor rescue for early RA treatment
MDedge Rheumatology
Testing for latent tuberculosis infection
MDedge Rheumatology