FDA Approves Biosimilar for Autoimmune Diseases

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

The FDA approved Pfizer's infliximab-qbtx (PF-06438179, Ixifi) for all eligible indications, including rheumatoid arthritis, 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

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.