Fresenius Kabi’s Biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and Subcutaneous tocilizumab biosimilar approved by the FDA

March 7, 2024

  • First tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA
  • Provides a comprehensive, accessible, and high-quality treatment option for U.S. patients treated with tocilizumab
  • Tyenne® expands Fresenius Kabi’s U.S. biosimilars portfolio focused on immunology and oncology
  • Tyenne® is Fresenius Kabi’s third approved U.S. biosimilar
  • Another landmark in the company’s Vision 2026 growth strategy

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 here.

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.

*https://www.fresenius-kabi.com/news/biosimilar-candidate-tocilizumab-accepted-for-review-by-FDA

** Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

*** Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.

**** Idacio® (adalimumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.

 

For more information about biosimilars, please visit https://biosimilars.fresenius-kabi.com.

For more information about biosimilars in the U.S., please visit https://biospecialized.com. 

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Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more.

With its purpose “Advancing Patient Care,” Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information, please visit www.fresenius-kabi.com.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Pierluigi Antonelli (Chairman), Yvonne Albert, Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Michael Schönhofen

Supervisory Board: Michael Sen (Chairman) Registered Office: Bad Homburg, Germany

Commercial Register: Amtsgericht Bad Homburg, HRB 11654