FDA Approves Stelara Biosimilar Ustekinumab-aauz (Otulfi)

The FDA has approved Fresnius Kabi and Formycon’s ustekinumab biosimilar, ustekinumab-aauz (Otulfi), for treating the same indications as reference ustekinumab (Stelara; Johnson & Johnson).¹

“The FDA approval of Otulfi™, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide. 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,” Sang-Jin Pak, MD, President Biopharma and member, Fresenius Kabi Management Board, said in a statement.¹

Ustekinumab-aauz was approved in both its subcutaneous and intravenous formulations for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis (PsA). Ustekinumab is an IL-12/IL-23-targeting human monoclonal antibody.

Earlier in 2024, Fresnius Kabi, Formycon, and Johnson & Johnson entered into an international settlement agreement ending all patent litigation, following an initial agreement in the US in 2023.^2,3 As per the settlement, the companies are permitted to market ustekinumab-aauz no later than April 15, 2025.

“Bringing more biosimilars treatment solutions to the U.S. market is a core commitment of the company’s Vision 2026 growth strategy. With our continuously expanding pipeline we are becoming a significant player in the evolving field of biosimilars. This agreement takes us a step closer to providing patient access to reliable, high-quality, and safe biologic therapies across the U.S. while reducing the burden on the health care system,” Dr. Michael Schönhofen, former President Biopharma, Fresenius Kabi, said in a statement at that time.³

Reference ustekinumab was originally approved by the FDA for treating psoriasis in 2009, followed by approvals for varying populations and severities of PsA, Crohn disease, ulcerative colitis, and psoriasis in the following years.⁴

Ustekinumab-aauz marks the drug’s fourth approved biosimilar, preceded by ustekinumab-ttwe’s (Pyzchiva; Sandoz) July 2024 approval, also for all approved indications of ustekinumab.⁵ Notably, ustekinumab-auub (Wezlana; Amgen) is the only approved interchangeable biosimilar.⁶ Ustekinumab-aekn (Selarsdi; Alvotech, Teva) is another approved bioosimilar.

"Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis,” Leah M Howard, JD, President and CEO of the National Psoriasis Foundation, said in an earlier statement.⁵ “Unfortunately, barriers to care, including costs, often prevent patients from getting the drug they are prescribed. Psoriatic disease is lifelong and chronic, leading to long-term treatment costs. Having more FDA-approved options can help make appropriate healthcare more affordable.”

REFERENCES

1. Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi™* (ustekinumab-aauz). News release. Fresnius Kabi. September 30, 2024. https://www.businesswire.com/news/home/20240930060447/en/Fresenius-Kabi-and-Formycon-Receive-U.S.-FDA-Approval-for-Biosimilar-Otulfi%E2%84%A2*-ustekinumab-aauz

2. Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada. News release. Formycon. March 18, 2024. https://www.formycon.com/en/blog/press-release/formycon-and-fresenius-kabi-reach-settlement-agreement-for-ustekinumab-biosimilar-candidate-fyb202-in-europe-and-canada/

3. Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar. News release. Formycon. August 7, 2023. https://www.formycon.com/en/blog/press-release/fyb202-settlement-agreement-us/

4. Stelara FDA Approval History. Drugs.com. Webpage. July 15, 2024. https://www.drugs.com/history/stelara.html

5. FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US. Sandoz.com. July 1, 2024. Accessed July 1, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/

6. Office of the Commissioner. FDA approves interchangeable biosimilar for multiple inflammatory diseases. U.S. Food and Drug Administration. Accessed October 31, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases.