FDA Approves Biosimilar to Rheumatoid Arthritis Drug

12/14/17

The US Food and Drug Administration (FDA) has approved a biosimilar to infliximab (Remicade, Pfizer) for the treatment of rheumatoid arthritis (RA).

The FDA approved infliximab-qbtx (PF-06438179, Ixifi) for all eligible indications, including RA, Crohn disease, pediatric Crohn disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Infliximab-qbtx is a chimeric human-murine (mAb) against tumor necrosis factor. It is administered intravenously at dosages based on disease type.

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

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

In addition, infliximab-qbtx comes with a boxed warning for serious infections, including tuberculosis and bacterial sepsis, and malignancies, which were reported among pediatric patients.—Melissa Weiss