FDA: Biosimilar To RA Drug Approved

The US Food and Drug Administration recently approved IXIFI (PF-06438179, infliximab-qbtx), as a biosimilar to Remicade (infliximab), for all eligible indications, including rheumatoid arthritis, Crohn disease, pediatric Crohn disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

IXIFI is a chimeric human-murine mAb against tumor necrosis factor. It is administered intravenously at dosages based on disease type.
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Approval for IXIFI was based on evidence that demonstrated a high degree of similarity between the biosimilar and Remicade.

Common adverse reactions included infections, such as sinusitis and pharyngitis, infusion-related reactions, headaches, and abdominal pain.

In addition, IXIFI comes with a boxed warning for serious infections, including tuberculosis and bacterial sepsis, and malignancies, which were reported among pediatric patients.

—Melissa Weiss

Reference:

FDA approves new Pfizer biosimilar [press release]. New York City, NY: Pfizer Inc.; December 13, 2017. https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_new_pfizer_biosimilar. Accessed December 14, 2017.