Fresenius Kabi, a subsidiary of Fresenius specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, along with Formycon AG, a leading developer of high-quality biosimilars, announced the approval of Otulfi™ (ustekinumab-aauz) by the U.S. Food and Drug Administration (FDA). Otulfi™, a biosimilar referencing Stelara®** (ustekinumab), has been approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks an important milestone in Fresenius Kabi’s efforts to expand its Biopharma platform, a key element of its #FutureFresenius strategy.
“The FDA approval of Otulfi™, our fourth biosimilar product in the U.S. market, is a significant step toward our goal of growing our biopharma portfolio both domestically and globally. This aligns with our Vision 2026 growth strategy, as we aim to be a major player in the biopharma industry and provide vital treatment options for patients worldwide,” said Dr. Sang-Jin Pak, President of Biopharma and a member of Fresenius Kabi’s Management Board.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar, covering major international markets.
Ustekinumab is a human monoclonal antibody that targets interleukin-12 and interleukin-23, which play a crucial role in inflammatory and immune responses. The FDA approval of Otulfi™ (ustekinumab-aauz) follows a rigorous evaluation of a comprehensive data package, including analytical, pre-clinical, clinical, and manufacturing data. In clinical trials, Otulfi™ demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to Stelara® in patients with moderate to severe plaque psoriasis.
Otulfi™ is available in both subcutaneous and intravenous formulations, providing healthcare professionals and patients in the U.S. with an alternative treatment option. It is contraindicated in patients with severe hypersensitivity to ustekinumab or any of its excipients. For detailed safety information, please refer to the Important Safety Information for Otulfi.
This approval marks Fresenius Kabi’s fourth U.S. biosimilar, following the authorizations of Idacio®* (adalimumab-aacf), Tyenne®* (tocilizumab-aazg), and Stimufend® (pegfilgrastim-fpgk). Fresenius Kabi continues to grow its pipeline of autoimmune and oncology biosimilars, with multiple candidates in various stages of development.
