FDA Approves Another Biosimilar for RA Drug

The US Food and Drug Administration (FDA) has approved a biosimilar to infliximab (Remicade, Pfizer).

The FDA approved Pfizer's Ixifi (PF-06438179, infliximab-qbtx) 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.

Approval for Ixifi was based on evidence that demonstrated a high degree of similarity between the biosimilar and infliximab.

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

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