- Tyenne® is the first tocilizumab biosimilar by Fresenius Kabi, an operating company of Fresenius, with an intravenous and subcutaneous formulation approved by the FDA.
- The tocilizumab biosimilar provides increased access and an affordable, high-quality, and safe treatment option for U.S. patients.
- Encouraging trajectory of the (Bio)Pharma business in 2024 so far.
- The launch of the tocilizumab biosimilar contributes directly to growing Fresenius’ (Bio)Pharma platform, a substantial cornerstone of the #FutureFresenius strategy.
Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra®** (tocilizumab). Tyenne®, for use in the treatment of chronic autoimmune diseases, is available in an intravenous (IV) formulation.
Michael Sen, CEO of Fresenius: “With the launch of Tyenne® in the U.S., we have reached another important milestone in accelerating our strong (Bio)Pharma momentum going into 2024. Growing this platform is a substantial cornerstone of our #FutureFresenius journey. Overall, we have seen an encouraging performance of our (Bio)Pharma business so far. We are particularly happy with the good progress of our majority-owned biotechnology company mAbxience and the traction of Tyenne®.”
Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. The biosimilar received FDA approval on March 5, 2024. Tyenne® is Fresenius’ third approved biosimilar available in the U.S. and the second within its immunology portfolio. The biologic medicine is indicated for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Pierluigi Antonelli, CEO of Fresenius Kabi: “Tyenne® will impact the treatment landscape for inflammatory and immune diseases in the U.S. Reaching ever more patients with our state-of-the-art biopharma portfolio signals a clear growth path in a highly promising market segment. We will continue to roll out our comprehensive pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.”
Supported by Fresenius Kabi’s holistic support program for health care professionals and patients, the company’s biologic medicine provides wider access to more treatment options and contributes to the viability of health care systems. Next to its two available biosimilars, Idacio®*** (adalimumab) and Stimufend®**** (pegfilgrastim), Fresenius Kabi has a growing pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.
To learn more about how Fresenius Kabi provides comprehensive patient support for Tyenne® in the U.S. please click here.
With #FutureFresenius, Fresenius successfully set the course last year to become a leading therapy-focused company. In line with the strategy, Fresenius has simplified its structure, is sharpening its focus by concentrating on its operating companies Fresenius Kabi and Fresenius Helios and is continuously enhancing its performance.
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 was 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 for the U.S. 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 health care systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, will be available to patients and health care providers in the U.S. from launch.
About Fresenius Kabi
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. 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.
*Tyenne® is a registered trademark of Fresenius Kabi Deutschland GmbH.
**Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
***Idacio® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
****Stimufend® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
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, the availability of financing and unforeseen impacts of international conflicts.
Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra®** (tocilizumab).
Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA.
Tyenne® is the company’s third approved biosimilar available in the U.S. and the second within its immunology portfolio.
Michael Sen, CEO of Fresenius: “With the launch of Tyenne® in the U.S., we have reached another important milestone in accelerating our strong (Bio)Pharma momentum going into 2024. Growing this platform is a substantial cornerstone of our #FutureFresenius journey. Overall, we have seen an encouraging performance of our (Bio)Pharma business so far. We are particularly happy with the good progress of our majority-owned biotechnology company mAbxience and the traction of Tyenne®.”
*Tyenne® is a registered trademark of Fresenius Kabi Deutschland GmbH.
**Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
mAbxience, a Fresenius Kabi majority-owned group, and Teva Pharmaceuticals International have entered a licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. The agreement covers global markets, including in Europe and the United States.
Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care. mAbxience will leverage its expertise and its state-of-the-art facilities in Spain and Argentina to develop and manufacture the biosimilar product. #FutureFresenius
mAbxience, a Fresenius Kabi majority-owned group, and Teva Pharmaceuticals International have entered a licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. The agreement covers global markets, including in Europe and the United States.
Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care. mAbxience will leverage its expertise and its state-of-the-art facilities in Spain and Argentina to develop and manufacture the biosimilar product. #FutureFresenius
Fresenius Kabi and Formycon announced today that they have reached a settlement agreement with Johnson & Johnson for FYB202, a proposed ustekinumab biosimilar to Stelara®* in Europe and Canada. The terms of the settlement are confidential.
The agreement falls in line with Fresenius Kabi’s recent milestones in its Biopharma segment. The company has a track record of successful market entries in countries around the world. Fresenius Kabi’s consistently growing biosimilars portfolio is focused on oncology and immunology and set to bringing high-quality, affordable, and accessible treatment options to patients as well as healthcare providers in line with #FutureFresenius.
* Stelara® is a registered trademark of Johnson & Johnson
Fresenius Kabi and Formycon announced today that they have reached a settlement agreement with Johnson & Johnson for FYB202, a proposed ustekinumab biosimilar to Stelara®* in Europe and Canada. The terms of the settlement are confidential.
The agreement falls in line with Fresenius Kabi’s recent milestones in its Biopharma segment. The company has a track record of successful market entries in countries around the world. Fresenius Kabi’s consistently growing biosimilars portfolio is focused on oncology and immunology and set to bringing high-quality, affordable, and accessible treatment options to patients as well as healthcare providers in line with #FutureFresenius.
* Stelara® is a registered trademark of Johnson & Johnson
Fresenius Kabi 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 product in the U.S. commencing on the license dates, which are confidential.
Tyenne® is Fresenius Kabi’s third approved U.S. biosimilar and another landmark in the company’s growth strategy towards #FutureFresenius. Recent launches were Tyenne® to treat inflammatory and autoimmune diseases in the EU as well as Idacio® and Stimufend®, expanding treatment options for autoimmune diseases and cancer in the U.S.
* Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Fresenius Kabi 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 product in the U.S. commencing on the license dates, which are confidential.
Tyenne® is Fresenius Kabi’s third approved U.S. biosimilar and another landmark in the company’s growth strategy towards #FutureFresenius. Recent launches were Tyenne® to treat inflammatory and autoimmune diseases in the EU as well as Idacio® and Stimufend®, expanding treatment options for autoimmune diseases and cancer in the U.S.
* Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. The introduction adds another life-saving treatment to Fresenius Kabi’s broad oncology portfolio that offers lower-cost options for treating a wide range of cancers.
For more information, please see the website of Fresenius Kabi.
Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. The introduction adds another life-saving treatment to Fresenius Kabi’s broad oncology portfolio that offers lower-cost options for treating a wide range of cancers.
For more information, please see the website of Fresenius Kabi.