FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and cancer in the U.S.

(PRESS RELEASE) BAD HOMBURG, Germany, 7-Mar-2024 — /EuropaWire/ — Fresenius SE & Co. KGaA (ETR: FRE), an industry-leading, therapy-focused healthcare company, is pleased to announce that its subsidiary, Fresenius Kabi, a prominent global healthcare leader specializing in life-saving medications and technologies for critically and chronically ill patients, has received approval from the United States Food and Drug Administration (FDA) for Tyenne®* (tocilizumab-aazg). This approval is a significant milestone, as Tyenne® becomes the first tocilizumab biosimilar offering both intravenous (IV) and subcutaneous formulations. With this achievement, Tyenne® further establishes itself as a pioneering biosimilar referencing Actemra®** (tocilizumab). Under a confidential patent settlement agreement with Genentech, Fresenius Kabi has obtained the license to market Tyenne® in the U.S. in accordance with specified license dates.

Pierluigi Antonelli, CEO of Fresenius Kabi, expressed the company’s commitment to global accessibility to advanced and cost-effective medicines, impacting nearly 450 million patients annually. He said “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,. 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.”

Dr. Michael Schönhofen, President Biopharma at Fresenius Kabi, highlighted the importance of offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to patients with autoimmune diseases in the U.S. He commented, “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. 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 already been launched in over 10 countries globally, with additional launches planned between 2024 and 2025. FDA approval for Tyenne® encompasses treatment for various inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Fabrice Romanet, SVP of Innovation and Development at Fresenius Kabi Biopharma, emphasized Tyenne®’s compliance with rigorous FDA biosimilarity requirements, stating, “Tyenne® met the rigorous FDA requirements for biosimilarity and is another treatment option for patients and their healthcare providers. 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 Fresenius Kabi’s third FDA-approved biosimilar, following the launches of Stimufend®*** (pefilgrastim-fpgk) in February 2023 and Idacio®**** (adalilmumab-aacf) in July 2023. With a robust pipeline of immunology and oncology biosimilars in late-stage development, Fresenius Kabi solidifies its position as a global provider of injectable medicines. The company’s Vision 2026 growth commitment in biopharmaceuticals reinforces its dedication to healthcare providers and patients worldwide, establishing itself as a trusted supplier of medicines in the U.S. and beyond.

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. 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://biopharma.fresenius-kabi.com

For more information about biosimilars in the U.S., please visit Biosimilars – Fresenius Kabi USA (fresenius-kabi.com)

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

SOURCE: Fresenius SE & Co. KGaA/ Fresenius Kabi AG