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 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.
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 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.
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 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 drives forward the vision of Health Equity with signature.
- The company offers broad access to healthcare and affordable versions of high-quality medicines: Every year around 24 million patients seek medical treatment at Europe’s largest hospital chain. Fresenius Kabi markets affordable and high-quality medicines worldwide.
"Fresenius has been committed to improving the health of people worldwide for over 100 years. It is our firm belief that equal opportunity in healthcare is a moral obligation and economically beneficial for society. That is why we signed the world's most important cross-sector commitment to health equity to advance a common vision of health equity," said Michael Sen, Chief Executive Officer of Fresenius.
Fresenius has signed the World Economic Forum's Zero Health Gaps Pledge ahead of this year's World Economic Forum in Davos. This commitment to promoting equal opportunities in healthcare is part of the Global Health Equity Network (GHEN), which brings together key players from the public and private sectors to advance a shared vision of equitable healthcare in line with the UN Sustainable Development Goals (SDGs). To date, more than 80 companies have signed the world's first voluntary commitment of this kind. By signing the pledge, Fresenius commits to acting responsibly and working together for equal opportunities in healthcare.
"With our innovations and strong partnerships, we have been enabling the delivery of high-quality, cost-effective therapies to millions of people for many years. However, fair healthcare can only be achieved as part of a consistent climate and sustainability approach. We shall strive to continuously implement this holistic approach," said Management Board member Dr. Michael Moser, who is among others responsible for Sustainability.
Improving people's health and advancing patient care is Fresenius' corporate purpose and therefore also an important part of the company's ESG strategy. Every year around 24 million patients seek medical treatment at a Helios hospital. Fresenius markets low-cost biosimilars in around 40 countries.
The voluntary commitment is a response to the persistent and increasing global inequalities in health between and within countries: according to the World Economic Forum's pledge, the gap in life expectancy between Japan and Lesotho is 30 years. In the USA, the gap in life expectancy between black and white men is five years on average. The global climate crisis and health crises such as the Covid-19 pandemic have exacerbated these inequalities and the potential consequences of inaction.
The global, cross-sector pledge includes ten commitments to advance the shared vision of health equity. In this vision, all people have a fair and equitable opportunity to fulfill their human potential in all aspects of health and well-being.
Click here to read the full Zero Health Gaps Pledge with its ten key commitments and here to learn more about the Global Health Equity Network.
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.
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.