Fresenius Kabi and Formycon AG have announced that the United States Food and Drug Administration (FDA) has approved Otulfi(ustekinumab-aauz), a biosimilar of Stelara® (ustekinumab), for the treatment of various chronic conditions including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi’s fourth biosimilar product to receive FDA approval in the U.S., further expanding the company’s growing biopharmaceutical portfolio.

Dr. Sang-Jin Pak, President Biopharma and a member of the Fresenius Kabi Management Board, described the FDA approval as an important step in the company’s efforts to establish a robust biopharmaceutical presence in the U.S. and global markets. “In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” said Dr. Pak.

Otulfi is a human monoclonal antibody that targets interleukin-12 and interleukin-23, key cytokines involved in inflammatory and immune responses. The approval was based on comprehensive data demonstrating its comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug, Stelara®, in patients with moderate to severe plaque psoriasis. Otulfi will be available in both subcutaneous and intravenous formulations, providing healthcare professionals with versatile treatment options for managing the conditions it is approved for.

The approval follows Fresenius Kabi’s strategic global commercialization partnership with Formycon AG, which began in February 2023, to bring the ustekinumab biosimilar to key global markets. The collaboration is expected to further bolster Fresenius Kabi’s biopharmaceutical offerings and contribute to its momentum under the company’s FutureFresenius initiative.

Otulfi’s approval is also a significant addition to Fresenius Kabi’s existing lineup of biosimilars in the U.S., which includes Idacio® (adalimumab-aacf), Tyenne (tocilizumab-aazg), and Stimufend® (pegfilgrastim-fpgk). These products address a range of autoimmune and oncology-related conditions, solidifying the company’s presence in these critical therapeutic areas.

Fresenius Kabi remains committed to expanding its biopharmaceutical pipeline, with several new biosimilar molecules currently in early and late-stage development. The company is focused on offering high-quality and cost-effective treatment options that meet the needs of patients and healthcare providers worldwide.

About Fresenius Kabi

Fresenius Kabi is a global healthcare company specializing in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. Its extensive product portfolio includes complex biopharmaceuticals, clinical nutrition products, and I.V. generic drugs. The company’s biosimilar segment, in particular, focuses on autoimmune diseases and oncology treatments.

Under its “Vision 2026” strategy, which is part of the #FutureFresenius program, the company aims to enhance efficiencies in patient care and improve access to high-quality healthcare solutions globally. Fresenius Kabi’s products and services are widely used for the therapy and care of critically and chronically ill patients, supporting healthcare professionals in providing optimal care.