Fresenius Kabi and its license partner Formycon announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for FYB202, an Ustekinumab biosimilar candidate. FYB202 references Johnson & Johnson’s Stelara^®*, a human monoclonal antibody for the treatment of immune-mediated disorders. 

Fresenius Kabi is the commercialization partner. The acceptance of the MAA for review marks another milestone in the company’s Vision 2026 growth strategy.

For more information, please see the website of Fresenius Kabi. 

* Stelara^® is a registered trademark of Johnson & Johnson

Fresenius makes available €500.000 for immediate release to the German Red Cross (Deutsches Rotes Kreuz e.V.) as assistance for disaster relief efforts to people affected by the recent earthquake in Morocco and the flooding in Libya. This cash donation will support direct disaster relief efforts on site. In addition, Fresenius remains committed to providing assistance with much needed medical products from its own product portfolio in crisis situations. 

Fresenius makes available €500.000 for immediate release to the German Red Cross (Deutsches Rotes Kreuz e.V.) as assistance for disaster relief efforts to people affected by the recent earthquake in Morocco and the flooding in Libya. This cash donation will support direct disaster relief efforts on site. In addition, Fresenius remains committed to providing assistance with much needed medical products from its own product portfolio in crisis situations. 

mAbxience, a Fresenius Kabi majority-owned Group, today announced a strategic partnership with Abbott to commercialize several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets including Latin America, Southeast Asia, the Middle East, and Africa. The first molecules are expected to be launched in 2025. mAbxience will manufacture the biosimilars in its state-of-the art and Good Manufacturing Practices (GMP)-approved facilities in Spain and Argentina. Additionally, mAbxience will be responsible for driving the clinical milestones for some of the molecules still undergoing development. The biosimilars will be commercialized by Abbott.

This strategic partnership strengthens mAbxience’s global presence and expands access to cutting-edge healthcare solutions in underserved regions.