FDA Approves Fresenius Kabi’s Tyenne, a Biosimilar of Actemra for the Treatment of Autoimmune Diseases

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Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.¹

“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, biopharma, 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 healthcare systems around the world.”

Tyenne is an interleukin (IL)-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, according to the press release.¹

Back in November, Fresenius Kabi launched Tyenne after receiving approval in the European Union, becoming the first tocilizumab biosimilar focused on treating multiple inflammatory and immune diseases to be available in Europe. This includes rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS), and can be used to help treat COVID-19.²

“We are very proud to be the first company to introduce an affordable, high-quality, safe, and alternative tocilizumab treatment option for health care providers and patients living with inflammatory and immune diseases. Offering both subcutaneous and intravenous administrations, we believe that Tyenne will transform the treatment landscape, enhance patient outcomes, and reduce the financial strain on patients and healthcare systems. Our dedication to the well-being of patients and the advancement of healthcare is matched by our relentless expansion of our immunology & oncology portfolio which has made us a reliable partner within the biopharmaceutical space,” explained Schönhofen, in an earlier statement.

The European Commission first granted a marketing authorization of Tyenne in September, making it the first tocilizumab biosimilar to achieve this approval in Europe, with the treatment becoming set for availability in all member countries.³

“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 Fresenius Kabi, in the release. “With our third biosimilar approved in the US, the company makes a decisive difference for chronically ill patients in the country and continues on its pathway towards #FutureFresenius.”

References

1. Fresenius Kabi’s Biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and Subcutaneous tocilizumab biosimilar approved by the FDA. Fresenius Kabi. March 7, 2024. Accessed March 7, 2024. https://www.fresenius-kabi.com/us/news/fresenius-kabi-s-biosimilar-tyenne-tocilizumab-aazg-becomes

2. Fresenius Kabi Launches Tyenne®*, the First Approved Tocilizumab Biosimilar in the European Union. Fresenius Kabi. November 1, 2023. Accessed March 7, 2024.

3. Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval. Fresenius Kabi. September 19, 2023. Accessed March 7, 2023. https://www.fresenius-kabi.com/news/european-commission-approval-tyenne-tocilizumab-biosimilar