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.

Colon cancer is the second most common type of cancer in men and women. The risk of developing colon cancer, however, can be reduced with regular screenings. The gold standard diagnostic tool here is a colonoscopy, which is recommended in Germany for men from the age of 50 and women from the age of 55. It is recommended that people with a family history of colon cancer undergo this examination from the age of 40.
(Published: March 2024)
The colonoscopy ideally needs to be able to detect all of the precancerous stages. Such a precancerous stage refers to a change in the tissue that is not yet malignant but has the potential to develop into cancer. Some types of polyps – growths in the mucous membrane of the intestine that are often left to grow unnoticed over many years – are precancerous stages. With one type of polyp in particular, namely adenomas, there is a high risk that they will develop into colon cancer, and the larger the adenoma, the more likely the affected person is to develop cancer. Besides, there is also an extremely wide range of different types of polyps.

During a screening colonoscopy, the teams of medics need to ensure that all precancerous stages are reliably detected and removed. This is the only way to significantly reduce the risk of a malignant tumor developing. But the variety of different types means that it is sometimes difficult to reliably diagnose polyps. Sessile polyps or those that occur behind folds can be overlooked during even a thorough colonoscopy. For a long time, special endoscopic procedures have been used for this, with the aim of minimizing the rate of overlooked polyps.
But the latest development in colonoscopies is the use of artificial intelligence, whereby a computer algorithm detects polyps in the intestinal mucosa during an endoscopy. As soon as the computer has made a find and detected a polyp, it sets off an optical and acoustic signal, and the examining physician is notified of the finding. Various different artificial intelligence systems have already been approved for use in colonoscopies.

The state-of-the-art Colon Cancer Center in the Helios Dr. Horst Schmidt Hospital has been routinely using artificial intelligence in the diagnosis of intestinal polyps for a long time.
“The use of AI in preventive colonoscopies significantly increases the rate of polyp detection. This allows us to offer the patient a much more precise screening without additional risk for our patients”, says Prof. Dr. Ingmar Mederacke, Director of the Clinic for Gastroenterology, Hepatology and Endocrinology.
The reliability of these systems is incredibly high. Studies have shown that artificial intelligence leads to a significantly increased detection rate when it comes to polyps. And the good news is that doctors aren’t being replaced, but are instead able to use the computer to support their diagnostics. AI provides additional information that would be overlooked by the human eye.
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.

Morgan Stanley – European MedTech & Services Conference

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. They will advise Michael Moser, who is the Management Board member responsible for environmental, social and governance (ESG).
"As a leading healthcare company, we contribute with our products and services to improving access to high-quality healthcare. We see it as our responsibility to lead by example when it comes to environment, social, and governance. Consistent further development of our ESG agenda is therefore an integral part of our #FutureFresenius strategy. This is how we fulfill our corporate purpose of advancing patient care," said Michael Sen, CEO of Fresenius.
"Together with the newly established sustainability advisory board, we are working on a concrete sustainability plan for the next five years. We want to set new priorities within the company and find answers to the most pressing questions of our time. I am very much looking forward to further expanding our expertise in this crucial area and to working together with leading as well as inspiring advisors," said Michael Moser.
The ESG Advisory Board is going to aid in developing the company’s ESG program further. Its members are extremely knowledgeable in Fresenius' key areas of action in the field of sustainability: from the design and implementation of health concepts and climate protection, through corporate sustainability principles, to future-oriented management and sustainable leadership as well as sustainability transformation.
Fresenius is making good progress in the area of sustainability: It reduced its CO2 emissions by 22 percent compared to the base year of 2020, for example. Fresenius is thus on track to halve its CO2 emissions by 2030 and to be climate neutral by 2040. In order to achieve health equity and enable equal opportunities in healthcare even more efficiently, Fresenius committed to the World Economic Forum's Zero Health Gaps Pledge at the beginning of the year. Fresenius thus commits, among other companies and organizations, to acting responsibly for equal opportunities in healthcare.
The ESG Advisory Board consists of the following members:
- Anahita Thoms (chairwoman): Anahita Thoms leads Baker McKenzie's international trade practice in Germany and is a member of the EMEA Steering Committee für Compliance & Investigations. She is Global Lead Sustainability Partner for the Industrials, Manufacturing & Transportation industry group. She holds a seat on the National Committee of UNICEF Germany and the Board of Atlantik-Brücke. She has also been a member of the German government's Sustainable Finance Advisory Committee and the American Bar Association's International Human Rights Steering Committee.
- Fiona Adshead: Fiona Adshead is the former Deputy Chief Medical Officer in the UK Government and a leading expert on sustainability and health. She currently chairs the Sustainable Healthcare Coalition, an organization that brings partners together to promote sustainable healthcare.
- Fabian Kienbaum: Fabian Kienbaum has been a managing partner in the third generation at Kienbaum since 2014 and has co-led the company together with Dr. Bibi Hahn since 2021. He focuses on advising family businesses on corporate governance and succession planning, and is the author of numerous publications on leadership and New Work.
- Prof. Judith Walls: Judith Walls is Chair of Sustainability Management and Director of the Institute for Economy and the Environment at the University of St. Gallen. She conducts research at the intersection between business and environmental sustainability.
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.