FDA Approves First Biosimilar to Tocilizumab to Treat Adults, Pediatric Patients With Arthritis

Jessica Ganga

Tocilizumab-bavi—a biosimilar to tocilizumab—has been approved by the FDA to treat adult and pediatric arthritis. This is the first biosimilar to tocilizumab to be approved by the FDA, as well as the first to be approved to treat systemic juvenile idiopathic arthritis.

The approval follows and is based on a comprehensive review of scientific evidence, which demonstrates that there are no clinically meaningful differences between tocilizumab-bavi and tocilizumab. The results of the comparisons confirmed the similarity of the safety and efficacy of both medications.

Tocilizumab-bavi is an interleukin-6 receptor antagonist that targets specific inflammatory proteins to suppress a patient’s immune system. The treatment is approved for the following indications:

  • Rheumatoid arthritis in adults
  • Polyarticular juvenile idiopathic arthritis ages 2 and older
  • Systemic juvenile idiopathic arthritis ages 2 and older

The most common adverse effects include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased alanine transaminase, and injection site reactions.



FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. News release. US Food and Drug Administration; September 29, 2023. Accessed November 15, 2023. www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis