Stelara (ustekinumab) biosimilars are now available from multiple suppliers in the US, after Teva, Sandoz and Biocon Biologics confirmed launches under settlements with originator J&J, while several other approved versions were also expected to imminently hit the market.
However, the latest indications suggest that price competition is going to be aggressive in the ustekinumab arena, with Biocon Biologics indicating a price 90% lower than Stelara, Teva confirming discounting at the 85% level and Sandoz entering the market at an 80% discount – evoking previous experiences with the launch of Humira (adalimumab) biosimilars at similarly high discounts in 2023.
This follows on from indications last week that Formycon – which has an approved Stelara biosimilar, Otulfi (ustekinumab-aauz), lined up for an imminent US launch with partner Fresenius Kabi – was having to significantly recalibrate its expectations and adjust its valuation of the product ahead of launch due to “an emerging, significantly higher-than-expected price discount” for ustekinumab biosimilars in the US.
Formycon CEO Stefan Glombitza reflected that “for biosimilars in the so-called Pharma Benefit market segment in the US, it is becoming apparent that the market opening for biosimilars is still progressing slower and requires greater price discounts than previously anticipated. This will also affect our product.”
The latest biosimilars hitting the market follow the debut of Amgen’s interchangeable Wezlana (ustekinumab-auub) biosimilar version with little fanfare at the start of this year. While Amgen confirmed to Generics Bulletin that it had entered into a collaboration agreement with Optum’s Nuvaila to manufacture Wezlana for Nuvaila, the firm offered no further details of the 1 January launch – including the pricing strategy for Wezlana – and further enquiries to Optum prompted no response.
Teva And Alvotech Launch Selarsdi
One biosimilar confirmed to be among the latest wave of launches is the Selarsdi (ustekinumab-aekn) version developed by Alvotech and marketed in the US by Teva under a nine-product partnership between the two firms. The biosimilar had been approved back in April 2024, with a full suite of indications secured later in the year.
Announcing the launch, Teva underlined that the US Food and Drug Administration had “provisionally determined that Selarsdi will be interchangeable with the reference biologic Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on 30 April 2025.”
“Biosimilars like Selarsdi create opportunities for cost savings across the healthcare system, and we are proud to be able to introduce our second biosimilar treatment option in partnership with Alvotech to US patients and providers,” commented Thomas Rainey, Teva’s senior vice president for US biosimilars, referring to the pair’s previous launch last year of the Simlandi (adalimumab-ryvk) rival to Humira .
Meanwhile, Anil Okay – chief commercial officer at Alvotech – said the US launch of Selarsdi “is an important step for our partnership and reaffirms a joint commitment to providing more affordable treatment options for US patients.”
Teva disclosed to Generics Bulletin that while “pricing may vary”, it was introducing Selarsdi at an 85% discount to Stelara’s wholesale acquisition cost.
“Teva is committed to helping patients gain affordable access to our medicines,” a spokesperson told Generics Bulletin. “For decades, we’ve offered assistance programs to improve patient access to our medicines and to help remove barriers to treatment. Eligible patients may receive their medication at no cost or may be eligible for assistance through our programs.”
And commenting on the general market landscape, Teva told Generics Bulletin that it was “committed to expanding the availability, access, and uptake of biosimilars in the US,” indicating that “the biosimilars market in the US is evolving and is a marathon, not a sprint.”
As they announced the launch, Teva and Alvotech also noted that Alvotech “developed and produces Selarsdi using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara.” Alvotech has previously sought to have the FDA refuse an interchangeability designation for other biosimilars that use a different type of cell line.
Sandoz And Samsung Bioepis Introduce Pyzchiva
Another biosimilar confirmed to have launched is the Pyzchiva (ustekinumab-ttwe) version developed by Samsung Bioepis that will be marketed by Sandoz. “From today, the medicine is commercially available to patients across the US,” Sandoz indicated.
When Pyzchiva was approved midway through last year, Sandoz revealed that the FDA had granted a “provisional determination for interchangeability designation,” with the firm only blocked by “an unexpired period of exclusivity for the first interchangeable biosimilar biological products.” And as the firm announced the launch, it said it “expected to offer interchangeability in the first half of 2025.”
Responding to Generics Bulletin enquiries over the firm’s pricing strategy, a Sandoz spokesperson said “Sandoz prices its medicines thoughtfully based on the value they bring to patients and the savings they bring to the healthcare system. Pyzchiva is available at a list price, or wholesale acquisition cost, of 80% below the current Stelara list price.”
But no further details were offered on the recently-disclosed pharmacy benefit manager agreement that Sandoz has struck for Pyzchiva in the US market following the firm’s success with its Hyrimoz (adalimumab-adaz) rival to Humira through its partnership with CVS’s Cordavis. “Yes, Sandoz has entered into a private label agreement to expand the reach of ustekinumab in the US,” the spokesperson confirmed, “though they cannot disclose specifics of the deal terms.”
Sandoz said the launch of Pyzchiva, “which builds on the US launch of Hyrimoz in July 2023, marks an important step in the Sandoz strategic ambition to become number one in biosimilars in the US.” The firm’s North America president Keren Haruvi described the launch as “an important moment for millions of patients living with chronic autoimmune diseases” and a move that “reinforces our commitment to broaden access to treatment options for patients, while helping to build a more sustainable healthcare system in the US so that everyone can access the medicines they need, when they need them.”
Similarly, Linda MacDonald, executive vice president and head of the global commercial division at Samsung Bioepis, said the launch was “a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US,” adding that “the expanded treatment options in the market would allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system.”
Meanwhile, Sandoz also pointed out that Pyzchiva offered “extended stability” compared to Stelara, “including the ability to be re-refrigerated, unlike the reference medicine.”
Biocon Launches Yesintek
The third Stelara biosimilar confirmed as having launched in the US in the past few days is Biocon Biologics’ Yesintek (ustekinumab-kfce) version, which was approved late last year.
Shreehas Tambe, CEO and managing director of Biocon Biologics, said the launch “marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars.”
At the same time, Tambe said, “it also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar ustekinumab to this patient population.”
Biocon Biologics told Generics Bulletin that its wholesale acquisition cost for a 90mg pre-filled syringe – “the dominant SKU” – was “approximately $3K, reflecting a ~90% discount compared to the originator’s WAC, making it the lowest-priced ustekinumab biosimilar.”
“However, WAC alone does not provide a complete picture of pricing,” the firm said. “Net price – factoring in payer rebates, DSA fees, patient services, and other elements – offers a more accurate representation. Considering these factors, we anticipate that the net prices of other biosimilars will fall within a similar range."
Commenting more broadly on pricing, Biocon said that “since launching our first biosimilar, we have remained committed to delivering significant savings for healthcare systems and patients – a commitment we continue with Yesintek."
The company indicated that its ustekinumab biosimilar “will have commercial payor coverage at launch and also have a robust patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients that meet the program criteria may pay as little as $0.”
More Approved Stelara Biosimilars Are Lining Up To Launch
Other versions of Stelara that have been approved by the FDA but have not yet confirmed launch are the Otulfi version from Fresenius Kabi and Formycon – which had recently been pencilled in by the firms for a 22 February launch, moved up from the original settlement date of 15 April.
Similarly, Celltrion – which received the most recent FDA approval to date for a Stelara biosimilar in mid-December, as the agency endorsed its Steqeyma (ustekinumab-stba) version – has also previously disclosed plans to launch in February, despite having originally settled with J&J on terms that allowed launch from 7 March 2025.
Completing the set of seven Stelara biosimilars to have thus far been approved by the FDA is Dong-A ST/Meiji Seika Pharma and Accord’s Imuldosa (ustekinumab-srlf) version, which was approved in October. While Accord had originally announced a settlement with J&J allowing a US launch “no later than 15 May 2025,” it has not yet been confirmed whether the firm will move the launch up to February as with other competitors.
And if the market for ustekinumab biosimilars already sounds crowded, there are even more versions on the way that have not yet been approved. Hikma – a newcomer to US biosimilars in general – was candid in recently admitting that it was “not going to be an easy market,” having partnered with Bio-Thera for development of its BAT2206 ustekinumab candidate that was filed with the FDA in July.
Whether the biosimilars market for Stelara mirrors that of Humira – which saw only very gradual uptake over its first year, as the originator held on to significant volumes through its contracting arrangements – remains to be seen. However, with so many rivals already having launched, it is clear that there will be no shortage of biosimilar ustekinumab suppliers to compete for market share.
Editor’s note: this article was updated on 24 February to include confirmation of pricing details from Teva and Sandoz; and updated again on 25 February to reflect pricing details from Biocon Biologics.