Our Portfolio of Biosimilars

Fresenius Kabi has an industry-leading portfolio of 6 FDA-approved biosimilar products in immunology and oncology and a growing pipeline

We have launched biosimilars in Europe, Australia, and Canada—turning the promise of effective and affordable biologic therapies into reality for many patients.  
 


We have a growing pipeline of biosimilars that includes candidates in immunology, oncology, and multiple other disease areas.  

FDA, U.S. Food and Drug Administration. 

References:

1. Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab). News Release. Fresenius Kabi. December 14, 2022. Accessed March 15, 2025.

2. Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement. March 27, 2025. Accessed May 5, 2025.

3. Fresenius Kabi and Formycon receive U.S. FDA approval for biosimilar Otulfi™ (ustekinumab-aauz). News Release. Fresenius Kabi. September 30, 2024. Accessed May 5, 2025.

4. Stimufend® (pegfilgrastim-fpgk) a Fresenius Kabi biosimilar receives FDA approval. News Release. Fresenius Kabi. September 6, 2022. Accessed March 15, 2025. 

5. Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA. News Release. Fresenius Kabi. March 7, 2024. Accessed March 15, 2025.