The FDA has approved Otulfi (ustekinumab-aauz), a biosimilar to Stelara (ustekinumab), for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This approval marks a significant step toward expanding treatment options and potentially reducing healthcare costs for patients with these chronic inflammatory conditions.
Developed by Formycon and commercialized by Fresenius Kabi, Otulfi is a human monoclonal antibody that targets interleukin-12 and interleukin-23, key cytokines involved in inflammatory and immune responses. The FDA's decision was based on a comprehensive review of analytical, preclinical, and clinical data, demonstrating that Otulfi is comparable to Stelara in terms of efficacy, safety, pharmacokinetics, and immunogenicity.
Clinical Equivalence Demonstrated
Clinical trials have shown that Otulfi has comparable efficacy to Stelara in treating moderate to severe plaque psoriasis. According to Fresenius Kabi, Otulfi demonstrated similar efficacy and safety profiles to Stelara in clinical trials. This includes data from the Phase 3 VESPUCCI study, which compared Otulfi to Stelara in patients with moderate to severe plaque psoriasis and met its primary endpoint, demonstrating similar efficacy based on the percent improvement in Psoriasis Area and Severity Index (PASI) score at week 12.
Market Entry and Availability
Following a patent settlement between Fresenius Kabi, Formycon, and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi in the U.S. no later than February 22, 2025. This timeline aligns with the expected entry of other Stelara biosimilars into the U.S. market, potentially creating a competitive landscape that could drive down prices and improve patient access.
Industry Impact
The approval of Otulfi is Fresenius Kabi’s fourth biosimilar product in the U.S. market, following Idacio (adalimumab-aacf), Tyenne (tocilizumab-aazg), and Stimufend (pegfilgrastim-fpgk). Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, stated that the approval is an important milestone in broadening their biopharma portfolio and offering essential treatment options for patients globally.
Expanding Treatment Access
With global sales of Stelara exceeding $10 billion in 2023, the introduction of biosimilars like Otulfi is expected to significantly impact the market. Biosimilars offer a more affordable alternative to the reference product, potentially increasing access to life-changing therapies for a broader patient population. As Dr. Stefan Glombitza, CEO of Formycon AG, noted, only a limited number of patients worldwide have access to biologic therapies for chronic inflammatory diseases, and improving access to biosimilars is a crucial step in addressing this unmet need.
Selarsdi Receives Expanded FDA Approval
In related news, Teva Pharmaceuticals and Alvotech announced that the FDA has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130 mg/26 mL solution in a single-dose vial for intravenous infusion. This approval expands the label to include the treatment of adults with Crohn’s disease and ulcerative colitis. The U.S. launch of SELARSDI for all indications is expected in the first quarter of 2025.
