Fresenius Kabi today announced the launch of Cetrorelix Acetate for Injection Kit, an FDA-approved, cost-effective, generic option for women’s health. Cetrorelix Acetate for Injection is a therapeutic equivalent to EMD Serono’s Cetrotide®.
With this new generic, Fresenius Kabi underscores its commitment to providing a comprehensive range of cost-effective treatment options in the field of women’s health, helping to support their options in the U.S.
For more information, please see the website of Fresenius Kabi.
Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.
The positive CHMP opinion is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.
Stelara® is a registered trademark of Johnson & Johnson
Fresenius, via its operating company Fresenius Kabi, announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Applications (MAAs) for its biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab).
The two applications include all indications covered by the reference products, respectively, for treating different conditions including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.1,2
The EMA Marketing Authorization Applications’ acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's Biopharma platform is a substantial cornerstone of #FutureFresenius.
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
1. European Medicines Agency (EMA). Prolia® (Denosumab): Prescribing Information. Available from: https://www.ema.europa.eu/en/documents/product-information/prolia-epar-product-information_en.pdf [Last accessed: June 2024].
2. European Medicines Agency (EMA). Xgeva® (Denosumab): Prescribing Information. Available from: https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf [Last accessed: June 2024].
Fresenius, via its operating company Fresenius Kabi, announced today the immediate availability of its biosimilar Tyenne® (tocilizumab-aazg) in a subcutaneous formulation in the U.S, continuing its (Bio)Pharma momentum.
With this launch Fresenius is increasing access to affordable and cost-effective treatment options for use in the treatment of chronic autoimmune diseases. This is another important milestone in accelerating the company’s strong (Bio)Pharma momentum, a substantial cornerstone of #FutureFresenius. Tyenne®, the company’s third biosimilar in the U.S., was launched in an intravenous (IV) formulation in April this year.
Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).
The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.
This BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
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
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.
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.