Your Location：Home>News Center >> Industry news >> FDA Approves Tyenne

FDA Approves Tyenne

FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

March 7, 2024 -- Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne®* (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra®** (tocilizumab). 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 U.S. commencing on the license dates, which are confidential.

“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. “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,” Dr. 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. Tyenne(tocilizumab-aazg) is FDA approved for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

“Tyenne met the rigorous FDA requirements for biosimilarity and is another treatment option for patients and their healthcare providers,” said Fabrice Romanet, SVP Innovation and Development, Fresenius Kabi Biopharma.
“Fresenius Kabi is leading the way as the first company to receive 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. Fresenius Kabi has a pipeline of immunology and oncology biosimilars in late-stage development. Fresenius Kabi is a global provider of injectable medicines and, with its Vision 2026 growth commitment in biopharmaceuticals, the company has established itself as a committed partner to healthcare providers and their patients, and as a reliable supplier of medicines in the U.S. and worldwide.

About Tyenne, a tocilizumab biosimilar

Tyenne (tocilizumab-aazg), a biosimilar to Actemra (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It has been 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. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving the product. Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne please see the full prescribing information.

Tyenne demonstrates Fresenius Kabi’s commitment to providing access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for healthcare systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, will be available to patients and healthcare providers in the U.S. from launch.

Hits：【Print】

Pre：Tislelizumab Plus Chemotherapy Beneficial for Resectable NSCLC Next：FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva