Fresenius Kabi receives FDA approval for biosimilar Idacio® (adalimumab) in the U.S.

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.