Fresenius, via its operating company Fresenius Kabi, announced today the immediate availability in the U.S. of itsbiosimilarTyenne® (tocilizumab-aazg), in a subcutaneous formulation, which will increase access to affordable and cost-effective treatment options for use in the treatment of chronic autoimmune diseases.
Tyenne is indicated for use in the treatment of chronic autoimmune diseases for certain indications of the reference product, Actemra® (tocilizumab). Fresenius Kabi previously launchedTyenne® in an intravenous (IV) formulation in April of this year.
“After successfully launching Tyenne in more than 10 countries, we are on track to continue the momentum in the U.S with the launch of a second formulation,” said Sang-Jin Pak, M.D., President of Biopharma at Fresenius Kabi. “Introducing our subcutaneous formulation demonstrates our continued commitment to providing greater access to more patients living with autoimmune diseases.”
Trial data that compared Tyenne® to the reference product, Actemra® showed similar safety and tolerability.
Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. Tyenne® received FDA approval on March 5, 2024, and an IV formulation was launched in April 2024 for use in the treatment of several inflammatory autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Tyenne® (tocilizumab-aazg), a biosimilar to Actemra® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Tyenne® includes a Boxed Warning for serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections that have occurred in patients receiving tocilizumab products. Tyenne® is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne®, please see the important safety information and full prescribing information for the U.S.
