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’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 has entered into a global license agreement to commercialize a Ustekinumab biosimilar candidate (FYB202) being developed by Formycon AG. The proposed biosimilar is currently in advanced clinical stage. FYB202 is a biosimilar candidate referencing Johnson & Johnson’s Stelara®*, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. Stelara is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The global license agreement gives Fresenius Kabi exclusive rights to commercialize the proposed Ustekinumab biosimilar product in key global markets.
*Stelara® is a registered trademark of Johnson & Johnson
Fresenius Kabi has entered into a global license agreement to commercialize a Ustekinumab biosimilar candidate (FYB202) being developed by Formycon AG. The proposed biosimilar is currently in advanced clinical stage. FYB202 is a biosimilar candidate referencing Johnson & Johnson’s Stelara®*, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. Stelara is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The global license agreement gives Fresenius Kabi exclusive rights to commercialize the proposed Ustekinumab biosimilar product in key global markets.
*Stelara® is a registered trademark of Johnson & Johnson
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.
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.
The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s biosimilar Idacio®, a citrate-free formulation of adalimumab. Idacio® (adalimumab) is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira®**.
With Idacio Fresenius Kabi expands its U.S. biosimilars portfolio focused on immunology and oncology. It is the company’s second approved biosimilar in the U.S. launching from July 2023 in accordance with the relevant patent settlement agreement with Abbvie.
* Idacio® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
**Humira® is a registered trademark of AbbVie, Inc.
The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s biosimilar Idacio®, a citrate-free formulation of adalimumab. Idacio® (adalimumab) is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira®**.
With Idacio Fresenius Kabi expands its U.S. biosimilars portfolio focused on immunology and oncology. It is the company’s second approved U.S. biosimilar launching from July 2023 in accordance with the relevant patent settlement agreement with Abbvie.
* Idacio® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
**Humira® is a registered trademark of AbbVie, Inc.
Fresenius Kabi introduced Pralatrexate Injection, a drug for the treatment of relapsed or refractory peripheral T-cell lymphoma in the U.S. Fresenius Kabi Pralatrexate Injection is a generic of Folotyn® and is available to customers immediately. It is the newest addition to the company’s injectable oncology medicine portfolio, the largest in U.S. health care.
*Folotyn® is a registered trademark of Acrotech Biopharma.