Fresenius Kabi, part of Fresenius and specializing in biopharmaceuticals, clinical nutrition, and medical technologies, along with Formycon AG, an independent developer of biosimilars, has announced FDA approval for Otulfi™ (ustekinumab-aauz), a biosimilar referencing Stelara® (ustekinumab). Otulfi™ is approved for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi’s fourth biosimilar product approved in the U.S., as the company aims to expand its Biopharma platform, a key component of its #FutureFresenius strategy.
Dr. Sang-Jin Pak, President of Biopharma at Fresenius Kabi, stated, “The FDA approval of Otulfi™ is a significant milestone as we work to broaden our biopharma portfolio in the U.S. and globally. We are committed to becoming a key player in the biopharma field and providing essential treatment options for patients worldwide.”
In February 2023, Fresenius Kabi and Formycon established a global partnership for the commercialization of the ustekinumab biosimilar.
Ustekinumab is a human monoclonal antibody that targets cytokines interleukin-12 and interleukin-23, crucial in inflammatory and immune responses. The FDA’s approval of Otulfi™ was based on a comprehensive evaluation of analytical, pre-clinical, clinical, and manufacturing data, showing comparable efficacy, safety, pharmacokinetics, and immunogenicity to Stelara® in patients with moderate to severe plaque psoriasis.
Otulfi™ will be available in both subcutaneous and intravenous formulations, offering a versatile treatment option for healthcare providers and patients in the U.S. It is contraindicated for patients with significant hypersensitivity to ustekinumab or its excipients.
Otulfi™ joins Fresenius Kabi’s expanding portfolio of biosimilars, which includes Idacio® (adalimumab-aacf), Tyenne® (tocilizumab-aazg), and Stimufend® (pegfilgrastim-fpgk). The company continues to develop additional autoimmune and oncology biosimilars.
