Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval
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 European Commission (EC) granted marketing authorization for its tocilizumab biosimilar Tyenne®, referencing RoActemra®** (tocilizumab), valid for all member states of the European Union.
Tyenne® becomes the first tocilizumab biosimilar to be granted marketing authorization in Europe for 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.
Pierluigi Antonelli, Fresenius Kabi CEO: “We are proud to be the first company to receive the marketing authorization for a tocilizumab biosimilar from the European Commission. The marketing authorization for Fresenius Kabi’s third biosimilar product in the European market is an important milestone on our pathway to consistently broadening our biopharma portfolio in the EU and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”
“Being on the cutting edge of proposing an affordable, high-quality, and safe tocilizumab treatment option to health care providers and patients living with autoimmune diseases is an exciting step in our mission to provide access to alternative treatment options. Tyenne® is our latest product in our expanding biosimilars portfolio for autoimmune and oncology related diseases, confirming our Vision 2026 commitments for biopharmaceuticals within Fresenius Kabi. Improving the quality of patients’ lives around the world, while easing the burden on health care systems, will continue to establish us as a trustworthy and reliable partner,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.
Fresenius Kabi received EC approval for both subcutaneous (prefilled syringe and autoinjector) and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with tocilizumab in Europe.
Tyenne® is the company’s third biosimilar granted marketing authorization by the EC, following previous approvals of its commercially available biosimilars Idacio®*** (adalimumab) and Stimufend®**** (pegfilgrastrim). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has 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