Fresenius Kabi and Formycon have entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed Ustekinumab biosimilar in the United States. Subject to regulatory approval, the settlement grants an entry date for FYB202 in the United States no later than April 15, 2025.
FYB202 is an Ustekinumab biosimilar candidate that references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders.
* Stelara® is a registered trademark of Johnson & Johnson
Fresenius Kabi’s tocilizumab biosimilar candidate, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). MSB11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases. This achievement marks a significant milestone in Fresenius Kabi’s Vision 2026 growth strategy.
For more information, please see the website of Fresenius Kabi.
Fresenius Kabi announced today that its biosimilar candidate FKS518, a denosumab biosimilar candidate for the US reference product Prolia®*, successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. For more information, please see the website of Fresenius Kabi.
*Prolia® is a registered trademark of Amgen Inc.
Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Ganirelix Acetate Injection, a generic fertility drug is part of the company’s expansion in women’s health. Ganirelix Acetate Injection is indicated for the inhibition of premature surges in luteinizing hormone, a chemical in the body that triggers reproductive processes such as ovulation. The second product is fentanyl citrate in a Simplist® ready-to-administer prefilled syringe presentation. The product is the only 100 mcg per 2 mL presentation available on the U.S. market in a manufacturer-prepared prefilled syringe.
Fresenius Kabi announced today the launch of its citrate-free biosimilar Idacio®* (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases, in the U.S. Idacio® (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira®** (adalimumab). Idacio® is Fresenius Kabi’s second biosimilar launched in the U.S. and another key milestone in the company’s Vision 2026 growth strategy to broaden its biopharma global reach.
* Idacio® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
**Humira® is a registered trademark of AbbVie, Inc.
- Dr. Ernst Wastler will leave the Fresenius Management Board upon reaching retirement age on July 18, 2023
- Changes and rejuvenation in the Management team of the Fresenius Vamed business segment
- Strengthened control function through new appointments in the reduced VAMED Supervisory Board and the establishment of an Audit Committee
- Following successful deconsolidation, Fresenius Medical Care will also no longer be represented on the Fresenius Board in future
- The composition of the Board reflects realignment through #FutureFresenius
The healthcare group Fresenius will have a revised Management team going forward. Dr. Ernst Wastler, previously responsible for Fresenius Vamed, will retire as Chairman of the VAMED Management Board and consequently from the Fresenius Management Board upon reaching retirement age on July 18, 2023. Dr. Klaus Schuster and Frank-Michael Frede will be appointed to the VAMED Management Board. Dr. Klaus Schuster will assume the new role of Spokesman of the VAMED Management Board but will not be represented on the Fresenius Management Board. Dr. Michael Moser, a new member of the Fresenius Management Board, will be responsible for Fresenius Vamed within the Fresenius Board.
Following the successful deconsolidation of Fresenius Medical Care, Helen Giza will also step down from the Fresenius Management Board. The #FutureFresenius strategy, with its realignment of business segments into operating and investment companies, is also reflected in the composition of the Fresenius Management Board.
"I would like to thank Dr. Wastler for his many years of highly dedicated work on the Fresenius Board," said Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius. "The leaner Fresenius Board in the future also takes into account the changes on the path to #FutureFresenius that Michael Sen and the Management Board team are successfully and consistently driving forward."
Dr. Klaus Schuster joined VAMED Management and Service GmbH as Chief Operating Officer (COO) in 2020. Schuster is a medical doctor and worked as a physician at Landesklinikum St. Pölten for ten years. He studied and obtained his doctorate at the Medical University of Vienna and holds an MBA in Health Care Administration from Danube University Krems.
Also appointed to the VAMED Board as of July 1, 2023, is Frank-Michael Frede, CEO of VAMED Deutschland Holding since 2022.
Gottfried Koos' (67) tenure on the VAMED Board will end on June 30, 2023. The four-member VAMED Board will continue to include the two current members, Andrea Raffaseder and Andreas Wortmann. Andreas Wortmann, Chief Financial Officer, will additionally take on the newly created role of Chief Transformation Officer.
Strengthened control function
The control function of the VAMED Supervisory Board will be strengthened. Firstly, it will be reduced from eight to six members. Commercial Councillor Karl Samstag, previously Deputy Chairman of the VAMED AG Supervisory Board and retired CEO of Austria Creditanstalt AG, as well as Dr. Robert Hink, former Secretary General of the Austrian Association of Municipalities, will resign from their positions with effect from the date of the next ordinary Supervisory Board meeting on July 12, 2023.
Dr. Dieter Schenk, Deputy Chairman of the Supervisory Board of Fresenius Management SE, will continue to lead the VAMED Supervisory Board. Sara Hennicken, CFO of Fresenius and a member of the VAMED Supervisory Board since December 2022, will remain a member of this Board and is due to be elected Deputy Chairman. Andreas Schmidradner, Advisor to the Management Board of B&C Industrieholding GmbH, will also continue to be a member of the Supervisory Board. Dr. Michael Moser, a future member of the Fresenius Management Board, was newly elected to the VAMED Supervisory Board with effect from July 12, 2023. Together with two employee representatives, Sara Hennicken, Dr. Dieter Schenk, Andreas Schmidradner and Dr. Michael Moser will form the six-member VAMED Supervisory Board going forward. Additionally, an Audit Committee consisting of Sara Hennicken as Chair, Michael Moser as Deputy Chair, and potentially one employee representative will be established.
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 Kabi expands its portfolio of critical care medicines by launching Vasopressin Injection, USP, a generic equivalent to Vasostrict®* in the U.S.
Fresenius Kabi Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
* Vasostrict® is a registered trademark of Par Pharmaceutical.
Fresenius Kabi’s Biosimilar Stimufend® (pegfilgrastim-fpgk) is now available from Fresenius Kabi in the United States. Stimufend® was approved by the U.S. Food and Drug Administration (FDA) in September 2022 for use in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is Fresenius Kabi’s first U.S. biosimilar launch. The expansion of the company’s global biosimilars portfolio with a focus on oncology and immunology is an important milestone in its Vision 2026 growth strategy.
* Stimufend® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend is a pegfilgrastim biosimilar medicine of Neulasta®, which is a registered trademark of Amgen Inc.
Fresenius Kabi’s innovative Ivenix Infusion System is recognized by KLAS Research in a Performance Insights First Look article. This report shares very positive customer experiences from health care organizations currently using the Ivenix Infusion System in the U.S. Ivenix, acquired in 2022 by Fresenius Kabi, offers a technologically advanced infusion system, including a large-volume pump, infusion management, software tools, applications, and analytics to inform care, advance efficiency, reduce infusion-related errors, and drive down the total cost of ownership.
Fresenius Kabi expands its portfolio of critical care medicine by launching Lacosamide Injection, USP, a generic equivalent to VIMPAT® in the U.S.
Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in the U.S. beginning today.
* VIMPAT® is a registered trademark of UCB, Inc.