Fresenius Kabi Launches Tyenne®*, the First Approved Tocilizumab Biosimilar in the European Union
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 the launch of its tocilizumab biosimilar Tyenne® referencing RoActemra®** (tocilizumab) in the European Union.
Tyenne® becomes the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) as well as for the treatment of COVID-19.
Tyenne® is Fresenius Kabi’s third approved biosimilar launched in Europe, offering patients and heath care providers a flexible range of user-friendly subcutaneous (prefilled syringe and autoinjector) and intravenous (vials) administration.
Supported by Fresenius Kabi’s holistic support program for health care professionals (HCPs) and patients, the company’s biologic medicine provides wider access to more treatment solutions and contributes to the long-term viability of health care systems in Europe.
Pierluigi Antonelli, CEO Fresenius Kabi: “Today’s launch is a great testimonial of our Vision 2026 growth strategy to offering essential treatment options for patients and health care professionals globally. The commercialization of tocilizumab in the European market strengthens our growth path to consistently broadening our biopharma portfolio of state-of-the-art medicines. Being the first health care company to offer a tocilizumab biosimilar in the EU showcases our ambition to be leading also in the biopharma segment.”
“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,” said Dr. Michael Schönhofen, President Fresenius Kabi Biopharmaceuticals.
Next to its two available biosimilars, Idacio®*** (adalimumab) and Stimufend®**** (pegfilgrastrim), Fresenius Kabi has a growing pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.
About Tyenne®, a tocilizumab biosimilar
Tyenne® (tocilizumab), is a biosimilar to the reference medicinal product RoActemra®, a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. Tocilizumab is a biological therapy approved in the EU for use in the treatment of various inflammatory and immune mediated conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) as well as for the treatment of COVID-19.
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 health care systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, is available to patients and health care providers from launch in Europe.
* Tyenne® (tocilizumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
** RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
*** Idacio® (adalimumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries and is already commercialized in 38 countries worldwide
**** Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
Fresenius Kabi is a global health care 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 corporate mission of "caring for life", 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 “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality health care 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.
Fresenius Kabi employs more than 42,000 people worldwide. In 2022, the company reported sales of more than €7.8 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA health care group.
For more information visit the company’s website at 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), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654