FDA Approves Biosimilar Tocilizumab-aazg for the Treatment of Autoimmune Diseases

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The drug is the first tocilizumab biosimilar with an FDA-approved intravenous and subcutaneous formulation.

The US Food and Drug Administration (FDA) has approved the tocilizumab biosimilar, tocilizumab-aazg (Tyenne), for the treatment of a variety of inflammatory and immune diseases, including rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and giant cell arteritis. The drug is the first tocilizumab biosimilar with an FDA-approved intravenous and subcutaneous formulation and marks the third biosimilar approval for Fresenius Kabi.1

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both intravenous and subcutaneous formulations to people living with autoimmune diseases in the US is a moment of great pride for Fresenius Kabi,” Michael Schönhofen, Dr. rer. Nat,Fresenius Kabi President Biopharma, said in a statement. “The FDA’s approval of our tocilizumab biosimilar is a breakthrough in bringing high-quality, affordable, and accessible autoimmune treatment options to patients and health care providers. We are expanding our biosimilars portfolio for immunology and oncology-related diseases, and we are committed to improving the quality of patients’ lives and lightening the burden on health care systems around the world.”1

The biosimilar, an interleukin-6 (IL-6) receptor antagonist, has currently been launched in more than 10 countries and will be available in additional countries in 2024 and 2025. It is offered in pen injector, vial, and prefilled syringe presentations.1

“Tyenne demonstrates Fresenius Kabi’s commitment to providing access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for health care systems,” stated the press release. “KabiCare, Fresenius Kabi’s comprehensive patient support program, will be available to patients and health care providers in the US from launch.”1


  1. Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA. Fresenius Kabi USA. March 7, 2024. Accessed March 7, 2024.