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.  
 

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.  
 

Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem®*. This is the second contrast agent introduced by Fresenius Kabi in the U.S. this year. 

Contrast agents are used by radiologists to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.

*Dotarem® is a registered trademark of Guerbet.
 

Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem®*. This is the second contrast agent introduced by Fresenius Kabi in the U.S. this year. 

Contrast agents are used by radiologists to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.

*Dotarem® is a registered trademark of Guerbet.
 

The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend®, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 
The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval. 
This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio. 

* Stimufend® (pegfilgrastim) 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. 
 

The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend®, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 
The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval. 
This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio. 

* Stimufend® (pegfilgrastim) 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. 
 

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing the company’s third biosimilar candidate submitted in the European Union. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. 

*RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.