FDA Approves First Tocilizumab Biosimilar for US Arthritis Patients


The indication for the intravenous formulation is for adults with RA, as well as adults and children with either active PJIA or systemic JIA.

FDA Approves First Tocilizumab Biosimilar for US Arthritis Patients

The US Food and Drug Administration (FDA) has approved tocilizumab-bavi (TOFIDENCE) a biosimilar option referencing ACTMRA, for the treatment of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (JIA).1

The new agent, from Biogen, is the first tocilizumab biosimilar approved for the US. In their statement announcing the approval, the company noted that autoimmune disease therapy spending has consistently increased by up to 25% annually over the last decade, per Association for Accessible Medicines data.2

“The approval of TOFIDENCE in the US 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 the statement. “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.”

The tocilizumab reference biosimilar was approved on the basis of findings from a randomized, double-blind, single-dose, parallel phase 1 trial data comparing the pharmacokinetics, safety and immunogenicity to both US and EU reference tocilizumab across 3 patient arms.

Another randomized, double-blind, multiple-dose, 3-arm phase 3 trial assessed the reference biologic to tocizilumab’s equivalent efficacy and comparable safety, pharmacokinetic and immunogenetic profiles in patients with RA inadequately controlled by methotrexate. Biogen reported that the totality of clinical and analytic evidence supported the reference biosimilar’s equivalence to tocizilumab.

The intravenous formulation is indicated for adult patients with moderately to severely active RA who had an inadequate response to ≥1 disease-modifying antirheumatic drug (DMARDs); patients ≥2 years old with active PJIA; and patients ≥2 years old with active systemic JIA.


  1. Biogen. FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®. Press release. Published September 29, 2023. https://investors.biogen.com/news-releases/news-release-details/fda-approves-biogens-tofidencetm-tocilizumab-bavi-biosimilar
  2. Association for Accessible Medicines. The U.S. Generic & Biosimilars Medicines Savings Report, September 2022. https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf Accessed August 2023.
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