FDA Approves Biosimilar to Rheumatoid Arthritis Drug
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.
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