3 Ustekinumab Biosimilars Launch on US Market

After Wezlana (ustekinumab-auub) became the first ustekinumab biosimilar to enter the market in January 2025,¹ 3 others joined the fray, expanding access to lower-cost versions of blockbuster Stelara (ustekinumab).^2-4

Samsung Bioepis/Sandoz, Biocon Biologics, and Teva/Alvotech launched their respective ustekinumab products: Pyzchiva (ustekinumab-ttwe), Yesintek (ustekinumab-kfce), and Selarsdi (ustekinumab-aekn).

Stelara, reference ustekinumab, generated $10.4 billion in sales in 2024, according to Johnson & Johnson’s most recent financial statement. | Image credit: Steve Cukrov - stock.adobe.com

When Amgen launched Wezlana, it launched a part of an exclusive agreement with Nuvalia, Optum Rx’s biosimilar procurement business comparable to CVS Health's Cordavis and Cigna/Express Scripts' Quallent.¹ Although Wezlana was the first ustekinumab biosimilar to receive FDA approval and first to launch, the Nuvaila deal partly limits access to patients, creating an opportunity for other FDA-approved biosimilars to fill the gap.

Overall, there are 7 ustekinumab. biosimilars approved by the FDA, all of which are slated to launch throughout 2025. In addition to the 4 on the market, there are Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), and Steqeyma (ustekinumab-stba).⁵ All 7 are approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

Ustekinumab biosimilars were originally expected in 2023; however, patent lawsuits brought about by Janssen and its parent company Johnson & Johnson (J&J) resulted in every biosimilar company looking to bring a Stelara biosimilar competitor to market being forced to delay their launches until the first half of 2025, with Amgen winning the first launch spot.⁶

Additionally, these products are looking to compete in a market where the reference drug generated $10.4 billion in sales in 2024, according to J&J’s most recent financial statement.⁷

Over 58.5 million American adults have been diagnosed with a rheumatic disease, with some estimates predicting psoriatic arthritis affects between 6% and 41% of patients with psoriasis.^8-9 Additionally, inflammatory bowel disease, which includes Crohn disease and ulcerative colitis, is estimated to impact between 2.4 million and 3.1 million Americans, according to the CDC.¹⁰

“The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available,” Laura Wingate, chief education, support, and advocacy officer of the Crohn’s and Colitis Foundation, commented.³

Biocon Biologics said that Yesintek will have commercial payer coverage at launch as well as a patient assistance product that includes verification and co-pay support, among other services. The program is similar to the one offered for the reference product, and eligible patients could pay as little as $0 for the biosimilar.

Pyzchiva and Selarsdi were developed as part of exclusive commercialization agreements between a smaller international company and a larger American corporation. In the case of Pyzchiva, Samsung Bioepis oversaw development, registration, intellectual property, manufacturing, and supply, while Sandoz manages commercialization.² Similarly, Selarsdi was developed by Alvotech and is commercialized by Teva.⁴

Of the 3 newly launched products, only Pyzchiva was approved with interchangeability,¹¹ meaning that pharmacists could substitute the reference drug with the biosimilar without waiting for provider approval, allowing patients to have easier access to their medications, particularly in the event of a drug shortage or supply chain issue.

References

1. 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

2. Samsung Bioepis announces US launch of Pyzchiva^® (ustekinumab-ttwe), biosimilar to Stelara. Press release. Samsung Bioepis; February 24, 2025. Accessed February 24, 2025. https://www.businesswire.com/news/home/20250223623917/en/Samsung-Bioepis-Announces-US-Launch-of-PYZCHIVA%C2%AE-ustekinumab-ttwe-Biosimilar-to-Stelara

3. Biocon Biologics launches Yesintek^™ (ustekinumab-kfce) biosimilar to Stelara® in the United States. Press release. Biocon Biologics; February 24, 2025. Accessed February 24, 2025. https://www.bioconbiologics.com/biocon-biologics-launches-yesintek-ustekinumab-kfce-biosimilar-to-stelara-in-the-united-states/

4. Teva and Alvotech announce Selarsdi^™ (ustekinumab-aekn) injection now available in the U.S. Press release. Teva Pharmaceuticals; February 21, 2025. Accessed February 24, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-and-alvotech-announce-selarsdi-ustekinumab-aekn-injection-now-available-in-the-u.s

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

6. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars. May 29, 2023. Accessed February 24, 2025. https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

7. Johnson & Johnson reports Q4 and full-year 2024 results. J&J. January 22, 2025. Accessed February 24, 2025. https://www.investor.jnj.com/news/news-details/2025/Johnson--Johnson-Reports-Q4-and-Full-Year-2024-Results/default.aspx#:~:text=2024%20Fourth%2DQuarter%20reported%20sales,quarter%20and%20full%20year%202024

8. American College of Rheumatology Releases 2022 Rheumatic Disease Report Card. Press release. American College of Rheumatology. September 15, 2022. Accessed February 24, 2025. https://rheumatology.org/press-releases/american-college-of-rheumatology-releases-2022-rheumatic-disease-report-card

9. Ogdie A, Weiss P. The epidemiology psoriatic arthritis. Rheum Dis Clin North Am. 2015;41(4):545-68. doi:10.1016/j.rdc.2015.07.001

10. IBD facts and stats. CDC. Accessed February 24, 2025. https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html

11. Jeremias S. FDA approves Samsung Bioepis’ Pyzchiva, a biosimilar to Stelara. The Center for Biosimilars. July 1, 2024. Accessed February 24, 2025. https://www.centerforbiosimilars.com/view/fda-approves-samsung-bioepis-pyzchiva-a-biosimilar-to-stelara