More Ustekinumab Biosimilars Join US Market Share Fight

With 4 already on the market, 2 more ustekinumab competitors are joining the fray, expanding access to lower-cost alternatives to blockbuster originator biologic, Janssen’s Stelara.1,2

"With this launch, we are expanding our immunology portfolio beyond [tumor necrosis factor]-alpha to include [interleukin]-12/23 inhibitors, offering more options for multiple immune-mediated diseases. To further enhance accessibility, Celltrion is actively collaborating with key pharmacy benefit managers to secure broader formulary coverage for Steqeyma,” praised Thomas Nusbickel, chief commercial officer at Celltrion USA, one of the companies behind one of the new products.1

Overall, there are 7 ustekinumab. biosimilars approved by the FDA, all of which are slated to launch throughout 2025 and were approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.3

In January, Amgen launched Wezlana through an exclusive agreement with Nuvalia, Optum Rx’s biosimilar procurement business, similar to CVS Health's Cordavis and Cigna/Express Scripts' Quallent.4 Although Wezlana was the first FDA-approved ustekinumab biosimilar and the first to market, its restricted access under the Nuvalia deal creates an opportunity for other FDA-approved biosimilars to meet patient demand.

However, 3 more ustekinumab biosimilars launched in February: Samsung Bioepis/Sandoz’ Pyzchiva (ustekinumab-ttwe), Biocon Biologics’ Yesintek (ustekinumab-kfce), and Teva/Alvotech’s Selarsdi (ustekinumab-aekn).5

The US welcomes 2 more Stelara alternatives, Celltrion’s Steqeyma (ustekinumab-stba) and Fresenius Kabi/Formycon’s Otulfi (ustekinumab-aauz).1,2

Although neither Fresenius Kabi nor Formycon disclosed the price of Otulfi in their statements,2,6 Steqeyma will have a wholesale acquisition cost (WAC) list price 85% lower than Stelara to enhance patient access to biologic treatments.1

“Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients," Mark G. Lebwohl, MD, Icahn School of Medicine at Mount Sinai, commented about the launch of Steqeyma.1

Otulfi will be available in the US as a 45-mg/0.5-mL and 90-mg/1-mL single-dose prefilled syringe for injection and a 130-mg/26-mL (5-mg/mL) single-dose vial for intravenous infusion.6 A 45-mg/0.5-mL single-dose vial for subcutaneous injection is expected to receive FDA approval in early 2025.

Steqeyma is available in subcutaneous (45-mg/0.5-mL [90-mg/1-mL] prefilled syringe) and intravenous (130-mg/26-mL [5-mg/mL] single-dose vial) formulations.1

“With the launch of Otulfi in these key global markets, patients, health care professionals, and payors will have access to a biosimilar with the same efficacy and safety as Stelara but at a lower cost. For many patients worldwide suffering from chronic inflammatory diseases, biologic therapies are inaccessible, and many patients experience significant delays before they can benefit from this highly effective treatment. The launch of Otulfi will provide enhanced treatment access and choice,” said Stefan Glombitza, CEO of Formycon.2

References

1. Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), now available in the United States. Press release. Celltrion; March 12, 2025. Accessed March 12, 2025. https://www.prnewswire.com/news-releases/steqeyma-ustekinumab-stba-a-biosimilar-to-stelara-ustekinumab-now-available-in-the-united-states-302399685.html

2. FYB202/Otulfi (ustekinumab-aauz), a biosimilar to Stelara, launched in the United States and the European Union. Press release. Formycon; March 3, 2025. Accessed March 12, 2025. https://www.formycon.com/en/blog/press-release/fyb202-otulfi-ustekinumab-aauz-a-biosimilar-to-stelara-launched-in-the-united-states-and-the-european-union/

3. Biosimilar approvals. The Center for Biosimilars®. Updated February 24, 2025. Accessed February 24, 2025. https://www.centerforbiosimilars.com/biosimilar-approvals

4. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed February 24, 2025. https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

5. Jeremias S. 3 ustekinumab biosimilars launch on US market. The Center for Biosimilars. February 24, 2025. Accessed March 12, 2025. https://www.centerforbiosimilars.com/view/3-ustekinumab-biosimilars-launch-on-us-market

6. Fresenius continues growth of biosimilars portfolio with the U.S. availability of Otulfi (ustekinumab-aauz). Press release. Fresenius Kabi; March 3, 2025. Accessed March 12, 2025. https://www.businesswire.com/news/home/20250303361545/en/Fresenius-Continues-Growth-of-Biosimilars-Portfolio-with-the-U.S.-Availability-of-Otulfi%C2%AE-ustekinumab-aauz