FDA approves Pfizer Biosimilar’s Ixifi (infliximab-qbtx)
FDA has approved Pfizer Biosimilar’s Ixifi (infliximab-qbtx) for multiple indications. IXIFI or PF-06438179, infliximab-qbtx is a chimeric human-murine monoclonal antibody or mAb against tumor necrosis factor, as a biosimilar to Remicade or infliximab for all eligible indications of the reference product.This is the third FDA-approved biosimilar to U.S.-licensed Remicade. For more information, see the approval letter and the labeling at Drugs@FDA.
The FDA has approved IXIFI as a treatment for patients with rheumatoid arthritis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
For more information about biosimilar products, visit www.fda.gov/biosimilars.
