Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®*, its Third Approved Biosimilar in the U.S.
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
April 15, 2024 · Fresenius Kabi
Brief News
mAbxience and Teva announce strategic global license agreement for biosimilar oncology treatment
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
April 04, 2024 · Fresenius Kabi
Brief News
Fresenius Management Board buys own shares
Members of the Fresenius Management Board purchased Fresenius shares with a total value of around €1.3 million over the past days as stipulated under the current compensation system. This underlines the commitment of the Management Board to drive the Company’s transformation at full speed. Fresenius is making strong progress in the Re-Vitalize phase of its journey towards #FutureFresenius. In 2024, which is expected to be a year of financial progression, the Company is focusing on deleveraging and pacing cost savings in order to build further earnings growth momentum and unlock value.
April 04, 2024 · Fresenius
Brief News
Fresenius Kabi and Formycon reach settlement agreement for ustekinumab biosimilar candidate
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 Supervisory Board extends contract of Chief Financial Officer Sara Hennicken ahead of time
March 08, 2024 · Fresenius
Brief News
Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA
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.
March 07, 2024 · Fresenius Kabi
Brief News
Fresenius Kabi Further Expands Oncology Portfolio with Launch of Cyclophosphamide for Injection, USP in the U.S.
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.
The Fresenius healthcare group has appointed an independent advisory board for sustainability issues. Four leading international experts from science, business, and consulting will in future support Fresenius in further development of its sustainability strategy.
Fresenius closes 2023 with a strong fourth quarter and expects accelerated earnings growth in 2024 through increasing momentum from #FutureFresenius
Michael Sen, CEO of Fresenius: “We took decisive actions in fiscal year 2023 and put Fresenius back on track. #FutureFresenius is driving improvements throughout the company and creating value.
February 21, 2024 · Fresenius
Brief News
Fresenius with top result in climate ranking, water ranking improved
The Fresenius Group achieved a sound climate-rating from the non-profit organization CDP of B. Further, our joint efforts as healthcare Group in increasing ESG reporting transparency and coordinated climate-related protection measures resulted in an improved water-ranking of B-. CDP is one of the most renowned climate and environmental rankings in the capital market. Investors use the annual results to evaluate climate protection activities and climate-related risks and opportunities of the companies assessed. As a healthcare Group, we have a special responsibility both to ensure the quality of our products and services, and protecting health and environment.
February 20, 2024 · Fresenius
Brief News
mAbxience announces CDMO agreement with Biosidus for the treatment of Fabry disease
mAbxience, a Fresenius Kabi majority-owned Group, today announced a CDMO agreement with Biosidus for the manufacture of the ingredient agalsidase beta used in the treatment of Fabry disease. Under the agreement, mAbxience will be responsible for the manufacture of the active ingredient, which is developed by Biosidus as a biosimilar of Fabrazyme®.
This agreement strengthens mAbxience position in the CDMO sector and demonstrates its ability to collaborate in the development and manufacture of complex, high-value treatments.
Fresenius successfully completes divestment of fertility services group Eugin
Fresenius has successfully completed the divestment of fertility services group Eugin. As announced in November 2023, global fertility group IVI RMA (a KKR portfolio company) and GED Capital acquired Eugin for up to €500 million including earn-outs. The transaction has received all regulatory approvals.
January 31, 2024 · Fresenius Helios
Brief News
Fresenius Kabi launches generic drug for the treatment of serious fungal infections in the U.S.
Fresenius Kabi announced today the immediate availability in the U.S. of Posaconazole Injection, a generic substitute for Noxafil®*, for the treatment or prevention of serious fungal infections. It is the newest addition to the company’s portfolio of more than 30 anti-infective molecules.
For more information, please see the website of Fresenius Kabi.
*Noxafil® is a registered trademark of Merck Sharp & Dohme LLC.
Fresenius signs Zero Health Gaps Pledge to promote equal opportunities in healthcare
January 12, 2024 · Fresenius
Brief News
mAbxience announces licensing agreement with Intas for Etanercept biosimilar
mAbxience, a Fresenius Kabi majority-owned Group, today announced a strategic licensing agreement with Intas Pharmaceuticals Ltd for Etanercept biosimilar to target autoimmune diseases. Under the agreement, mAbxience will develop, manufacture, and supply the Etanercept biosimilar from its state-of-the-art, Good Manufacturing Practices (GMP)-approved facilities, and Intas will receive the rights to commercialize in more than 150 countries, including Europe and the United States.
This collaboration demonstrates mAbxience’s commitment to addressing the pressing need for innovative and affordable treatment options for autoimmune diseases.
December 20, 2023 · Fresenius Kabi
Brief News
Fresenius Helios strengthens operational focus in digitalization
Fresenius Helios will be linking digitalization even more closely with its core activities in inpatient and outpatient healthcare. The company will strengthen areas such as the digitalization of clinical processes and clinical decision making, for example through the responsible use of artificial intelligence.
Furthermore, a Digital Innovation Officer within the German Helios organization will explore innovative directions in digitalization. The implementation of digitalization processes and solutions will be the core task of the newly created function of the Head of Transformation Management at Helios. Also Quirónsalud in Spain is successfully driving forward the expansion of its leading digital processes.
In this context, Fresenius Helios will discontinue the activities of Curalie, which specializes in health apps, from the end of 2023. The Curalie subsidiaries meditec and ibs will be sold. Respective binding agreements have been signed. The business operations of the parent company Curalie GmbH and its other subsidiaries will be discontinued. The measures are in line with #FutureFresenius' intention to further focus business activities and reduce complexity.
December 15, 2023 · Fresenius Helios
Brief News
Fresenius Kabi enters into multiyear supply and service agreement for its Ivenix Infusion System
Fresenius Kabi announced today it has signed a multiyear agreement under which the Mayo Clinic is expected to purchase 10,000 Ivenix large-volume infusion pumps for its hospitals and clinics in Minnesota, Arizona, and Florida. This is the largest contract for Ivenix pumps Fresenius Kabi has signed to date, testament of the stringent implementation of the company’s Vision 2026 strategy.