Fresenius Kabi’s Tyenne, a Biosimilar of Actemra, Is Approved to Treat Autoimmune Diseases

The U.S. Food and Drug Administration (FDA) has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), to treat multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Tyenne is the first tocilizumab biosimilar to be approved by FDA for intravenous (IV) and subcutaneous use. 

Tyenne is an interleukin-6 receptor antagonist that will be available in prefilled syringes, pen injectors and vial presentations. Serious infections have been reported for individuals receiving the biosimilar, including tuberculosis, bacterial, invasive fungal, viral and other infections. 

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. 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 healthcare providers,” said Michael Schönhofen, PhD, president of biopharma at Fresenius Kabi. “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 healthcare systems around the world.” 

This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalimumab-aacf), a biosimilar to Humira.