FDA Approves Intravenous, Subcutaneous Tocilizumab Biosimilar for Autoimmune Conditions

The US Food and Drug Administration (FDA) has approved tocilizumab-aazg, sold as Tyenne, which is the second approved tocilizumab biosimilar, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Tyenne is the first tocilizumab biosimilar available in both intravenous (IV) and subcutaneous formulations. The interleukin-6 receptor agonist is manufactured by Fresenius Kabi.

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the United States is a moment of great pride for Fresenius Kabi. 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,” said Dr. Michael Schönhofen, president of Biopharma at Fresenius Kabi, in a press release. “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.”

This medication comes with a boxed warning regarding the risk of serious infections leading to hospitalization or death. Tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving the product. Tyenne is contraindicated in patients with a known hypersensitivity to tocilizumab products.