Fresenius Kabi obtains FDA OK for biosimilar Tyenne

The Food and Drug Administration has approved Fresenius Kabi’s Tyenne (tocilizumab-aazg), a biosimilar of Roche Group’s Chugai Seiyaku Kabushiki Kaisha’s Actemra.

It is used in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. 

Tyenne becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the United States commencing on the license dates, which are confidential.

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“Fresenius Kabi is highly committed to enabling access to state-of-the-art and affordable medicines around the globe, with impact on almost 450 million patients’ lives annually. Our strong biosimilars pipeline stands exemplary for our ambitions,” said Pierluigi Antonelli, CEO of Fresenius Kabi. “With our third biosimilar approved in the U.S., the company makes a decisive difference for chronically ill patients in the country and continues on its pathway towards #FutureFresenius.”

“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, Fresenius Kabi president Biopharma. “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.”

Tyenne has launched globally in more than 10 countries, with plans to launch in many more countries between 2024 and 2025. 

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“Tyenne met the rigorous FDA requirements for biosimilarity and is another treatment option for patients and their healthcare providers,” said Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi Biopharma.e FDA approval for  both IV and subcutaneous formulations of its tocilizumab biosimilar and is available in prefilled syringe, pen injector and vial presentations."

Tyenne marks the company’s third biosimilar to receive FDA approval following the launch of Stimufend (pefilgrastim-fpgk) in February 2023, and Idacio (adalilmumab-aacf) in July 2023.