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LAKE ZURICH, Ill. - Fresenius Kabi, a health care company and part of the Fresenius Group, with a market capitalization of $447 million and a "FAIR" overall financial health rating according to InvestingPro, along with Formycon AG, has received the U.S. Food and Drug Administration’s (FDA) interchangeable biosimilar designation for Otulfi® (ustekinumab-aauz), matching the reference product Stelara® (ustekinumab). This status allows the biosimilar to be substituted for the original brand product at pharmacies across the United States without the need for prescriber approval, depending on individual state pharmacy laws.
Otulfi® is indicated for several conditions, including moderately to severely active Crohn’s disease and ulcerative colitis in adults, moderate to severe plaque psoriasis in adults and children six years or older, and active psoriatic arthritis in the same age group. The biosimilar was approved by the FDA in September 2024 and has been available in the U.S. market since March 2025.
The FDA’s designation is based on a comprehensive assessment of data that showed no clinically meaningful differences between Otulfi® and Stelara® in terms of safety, efficacy, or immunogenicity. This includes analytical, pre-clinical, clinical, and manufacturing data, ensuring patients can expect the same clinical outcomes with Otulfi® as with the reference product.
Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, expressed the company’s commitment to developing and commercializing biosimilars that provide accessible, high-quality, and affordable therapies. The company maintains a strong liquidity position with a current ratio of 2.8, though InvestingPro analysis indicates anticipated sales challenges in the current year. For deeper insights into the company’s financial health and growth prospects, investors can access comprehensive Pro Research Reports, available exclusively on InvestingPro. Otulfi® is the first biosimilar product launched in the U.S. from the partnership between Fresenius Kabi and Formycon AG, with the companies having entered a global commercialization partnership in February 2023.
Otulfi® targets interleukin-12 and interleukin-23, which are important in inflammatory and immune responses, and is available in both subcutaneous and intravenous formulations. It is the fourth Fresenius Kabi biosimilar in the U.S. market, following adalimumab-aacf, Tyenne® (tocilizumab-aazg), and Stimufend® (pegfilgrastim-fpgk), with several more molecules in early and late-stage development.
The interchangeable designation is a significant milestone for Fresenius Kabi and Formycon AG, reflecting a growing trend in the biosimilar market aimed at expanding patient access to essential treatments. While the company operates with a moderate debt level and maintains strong liquidity, its stock has experienced a significant 50.6% decline over the past six months. This news is based on a press release statement from Fresenius Kabi.
In other recent news, Formycon AG reported a significant decline in revenue for the first quarter of 2025, with figures dropping to €5.3 million from €17.7 million in the same period last year. Despite the downturn, the company maintains a solid cash position of €33 million and remains optimistic about revenue growth in the latter half of the year. Formycon has set a full-year revenue guidance of €55-60 million, anticipating a boost in the third and fourth quarters of 2025. The company continues to focus on its strategic partnerships and product pipeline, with recent approvals in Canada and the UK for FIB22 Otafi and the expansion of FIB-202 into new markets. Analysts have not indicated any changes in their ratings for Formycon, but the company’s cautious outlook for the first half of the year has contributed to some investor concern. CEO Stefan Blombitza emphasized the company’s commitment to biosimilars and its goal to achieve EBITDA profitability as early as next year. Formycon is also exploring potential licensing deals and advancing its clinical trials, which could positively impact future financial performance.
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