First four Stelara biosimilars launch in US; ‘white labeling’ threatens market ‘vibrancy’
Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference product manufacturer, Janssen Pharmaceuticals, which set timelines for their market entries.
Stelara (ustekinumab, Janssen) is an interleukin (IL)-12 and IL-23 inhibitor approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The FDA has approved seven biosimilars for the drug, though patent litigation has blocked their launches until now.
!["[White labeling] is bad for the vibrancy of the biosimilar market and seems to limit coverage of all of the biosimilars to just a 'chosen few,'" Madelaine Feldman, MD, FACR, said.](/~/media/slack-news/rheumatology/misc/infographics/2025/rh0225stelarabiosimilars_graphic_01.jpg?w=800)
The four ustekinumab biosimilars now available in the United States are:
- Wezlana (ustekinumab-auub, Amgen),
- Selarsdi (ustekinumab-aekn; Teva, Alvotech),
- Pyzchiva (ustekinumab-ttwe, Samsung Bioepis) and
- Yesintek (ustekinumab-kfce, Biocon).
Amgen’s Wezlana was the first to launch on Jan. 17. Selardsi later made its U.S. market debut on Feb. 21, while Pyzchiva and Yesintek launched on Feb. 24.
Wezlana was also given interchangeable status by the FDA, allowing pharmacists in some states to switch patients from the reference product to the biosimilar without notifying prescribers.
The FDA additionally “provisionally determined” Selarsdi will have interchangeable status after a period of exclusivity for Wezlana expires on April 30, according to a press release from Teva and Alvotech.
Through a private-label partnership, Wezlana is available exclusively through Nuvaila, a pharmaceutical commercialization business that is part of Optum Health, a health services subsidiary of UnitedHealth Group.
Coinciding with Wezlana’s launch, Optum Health stopped covering Humira (adalimumab, AbbVie) and several of its biosimilars for new patients. It now only private-labels Amgen’s own Humira biosimilar Amjevita (adalimumab-atto).
Private-label arrangements, also known as white labeling, are “the latest wrinkle in the biosimilar space,” Madelaine Feldman, MD, FACR, vice president of advocacy and government affairs for Coalition of State Rheumatology Organizations, told Healio.
“The big three pharmacy benefit managers (PBMs)/insurance companies have started subsidiaries that would ‘co-produce’ white-label biosimilars in partnership with specific biosimilar manufacturers,” she said. “Then they are covering only the biosimilars of the companies they have partnered with. These PBM subsidiaries would then make money on the selling of the drug, at the same time the vertically connected PBMs prefer that drug it on their formulary.”
No private-label deals have been announced for Pyzchiva, Selarsdi or Yesintek.
Feldman said she believes such private-label arrangements go against FTC rules from the 1990s that “would not allow a manufacturer to own a PBM and then prefer their own drug on the formulary.”
“It is bad for the vibrancy of the biosimilar market and seems to limit coverage of all of the biosimilars to just a ‘chosen few,’” she added. “I think this creates a disincentive for other biosimilar manufacturers to continue to enter the market if they are blocked for coverage by the white-label partnerships.”
More ustekinumab biosimilars are set to launch later this year, including Steqeyma (ustekinumab-stba, Celltrion) in March and Imuldosa (ustekinumab-srlf, Accord) in May.
References:
Amgen launches Wezlana as the first Stelara interchangeable biosimilar through Optum’s Nuvaila. https://www.jdsupra.com/legalnews/amgen-launches-wezlana-tm-as-the-first-5034283/. Published Jan. 17, 2025. Accessed Feb. 26, 2025.
Biocon Biologics launches Yesintek (ustekinumab-kfce) biosimilar to Stelara in the United States. https://www.bioconbiologics.com/biocon-biologics-launches-yesintek-ustekinumab-kfce-biosimilar-to-stelara-in-the-united-states/. Published Feb. 24, 2025. Accessed Feb. 26, 2025.
Teva and Alvotech announce Selarsdi injection now available in the U.S. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Alvotech-Announce-SELARSDI-ustekinumab-aekn-Injection-Now-Available-in-the-U.S/default.aspx. Published Feb. 21, 2025. Accessed Feb. 26, 2025.
Samsung Bioepis announces U.S. launch of Pyzchiva (ustekinumab-ttwe), biosimilar to Stelara. https://www.businesswire.com/news/home/20250223623917/en/Samsung-Bioepis-Announces-US-Launch-of-PYZCHIVA%C2%AE-ustekinumab-ttwe-Biosimilar-to-Stelara. Published Feb. 24, 2025. Accessed Feb. 26, 2025.
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