FDA Approves First Biosimilar of Arthritis Med Actemra

The FDA has approved Biogen’s Tofidence (tocilizumab-bavi) as first biosimilar to reference Genentech’s Actemra (tocilizumab). Tofidence is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system.

Tofidence is approved to treat rheumatoid arthritis in adults, polyarticular juvenile idiopathic arthritis in patients ages 2 and older, and systemic juvenile idiopathic arthritis in patients ages 2 and older. Tofidence, previously known as BIIB800, is administered via intravenous infusion.

Ian Henshaw

“The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” Ian Henshaw, global head of biosimilars at Biogen, said in a press release. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

Developed by Bio-Thera, Tofidence will be commercialized by Biogen in the United States. Biogen is still evaluating launch timeline, and information on pricing will be available closer to launch, according to a spokesperson.

The FDA approval of Tofidence was based on analytical, nonclinical and clinical data submitted by Biogen in September 2022. Additionally, a phase 1 study compared the pharmacokinetics, safety and immunogenicity of Tofidence with both the U.S. and EU reference tocilizumab in healthy volunteers, and parallel phase 3 study compared Tofidence with Actemra to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate.

The most common side effects associated with tocilizumab products are upper respiratory tract infections, common cold, headache, hypertension, elevated liver enzymes, and injection site reactions.