Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

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Earlier this month, the US market welcomed its first ustekinumab biosimilar, Amgen’s Wezlana (ustekinumab-auub), ushering in a new class of lower-cost biologics for Americans with a number of rheumatic and gastrointestinal conditions.¹

However, the biosimilar is only available through Nuvaila.² Nuvalia is a biosimilar procurement business, comparable to CVS Health's Cordavis and Cigna/Express Scripts' Quallent. Earlier this month, AIS Health reported on its exclusive arrangement with Nuvaila.

Wezlana was the first ustekinumab biosimilar to receive FDA approval and is 1 of 7 biosimilars for Stelara expected to launch in 2025.³ The other 6 products are Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Yesintek (ustekinumab-kfce), and Steqeyma (ustekinumab-stba), the last of which was approved at the end of December 2024.⁴

About Wezlana

Ustekinumab products are interleukin (IL)-12 and IL-23 antagonists used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. The originator product, Stelara, is available in intravenous and subcutaneous formulations. It’s also 1 of the first 10 products selected by CMS as part of drug price negotiations as part of the Inflation Reduction Act.⁵

The approval for Wezlana was based on a data from a phase 3 trial that confirmed the biosimilar, then dubbed ABP 654, as having comparable safety and efficacy profiles to the reference product.³

The study was a multicenter, randomized, double-blinded, comparative clinical trial, and it met the primary efficacy end point, indicating that the biosimilar had no clinically meaningful differences compared with Stelara. The analysis evaluated the change in percentage of the Psoriasis Area and Severity Index in adult patients with moderate to severe plaque psoriasis over 12 weeks. In total, 563 patients were randomized to receive either the biosimilar (n = 281) or the reference product (n = 282).

Wezlana also has an interchangeability designation, which allows for the biosimilar to substitute for Stelara at the pharmacy level without requiring a pharmacist to get permission from a provider first. The designation is intended to increase access to the biosimilar and convenience for patients, who often have to long wait times to obtain a medication because they have to wait for provider approval.

For a company to obtain interchangeability for a biosimilar, in most cases—excluding insulin products and products administered intravitreally—the company must conduct a switching study, in which patients are switched back and forth multiple times between the reference product and biosimilar to confirm that switching is safe and does not impact clinical outcomes.

In 2023, Amgen settled with Johnson & Johnson, the parent company of the maker of Stelara (Janssen), to delay its projected launch date for Wezlana from late 2023 to “no later than January 1, 2025.”⁶

Will Payers Embrace Ustekinumab Biosimilars?

With so many ustekinumab biosimilars slated to enter the US market around the same time, many are looking to the recent experience seen in the adalimumab space for signs of how the ustekinumab sector will play out.

Since January 2023, 10 adalimumab biosimilars referencing Humira (adalimumab) have entered the US market.⁷ According to a report by Samsung Bioepis, adalimumab biosimilars were only able to obtain 2% market share by the first anniversary of the first launch.⁸ However, as the year progressed, more pharmacy benefits managers 9PBMs) and payers started adding the biosimilars to formulary lists, propelling the combined market share for these products to 22% by October 2024, according to a Samsung Bioepis report.⁹ This was largely in thanks to PBM giant Caremark shifting its formulary to include Hyrimoz and remove Humira.¹⁰

“We'll have to see if the adoption by payers is similar or quicker [compared with adalimumab biosimilars]; we're just starting to have some success and conversion of Humira to biosimilars. We'll have to see how the payers adopt Stelara [biosimilars]. Maybe they've gained some more confidence and learned a little bit from the Humira introduction,” predicted Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at IPD Analytics, in an interview with The Center for Biosimilars^®.¹¹

Another big concern is “product hopping,” where drug companies shift demand from an innovator drug facing or about to face generic or biosimilar competition to new, patented versions.¹² The practice can hinder competition by allowing companies to maintain near-monopolies by shifting patients taking blockbuster products to other products made by the same company in order to extend market exclusivity, often without significantly improving clinical outcomes for patients.

This has been observed in the adalimumab space, with many patients shifting from Humira to Skyrizi (risankizumab-rzaa), another product made by the same manufacturer that has the same indications, enabling the product to become the company’s new sales driver.

Experts warned about this phenomenon impacting the adalimumab space at the GRx+Biosims conference, where they highlighted that the increase in market adoption of adalimumab biosimilars in 2024 is offset by the massive adoption of Skyrizi and subsequent dwindling adoption of adalimumab overall.¹³

“What happened is AbbVie recognized, ‘Hey, [the introduction of Humira biosimilars] will be a potentially disastrous market event with one of the biggest blockbusters in history losing exclusivity. We've got to compete. We've got to launch these other brands with similar indications and get them going.’ So, both these brands have really successful launches, and a lot of that has been due to moving patients over to these other products. And so, the total size of the adalimumab pie has really shrunk. So, even if biosimilars get the uptake, they're getting share in a market that is getting smaller and smaller,” explained panelist Nick Adolph, principal of US market access strategy at IQVIA Institute for Human Data Science.

Janssen, the maker of Stelara, does have another IL-23 antagonist in its arsenal to start moving patients on ustekinumab therapy to a new and shinier drug—Tremfya (gusekumab)—if they haven’t started already. Alas, it remains to be seen whether ustekinumab will follow the path of adalimumab. Nonetheless, 2025 is already kicking off to be a big year for the ustekinumab space.

References

1. Optum subsidiary Nuvaila will offer biosimilars of Stelara, Humira. AIS Health. Sep 12, 2024. Accessed January 31, 2025. https://aishealth.mmitnetwork.com/blogs/radar-on-specialty-pharmacy/optum-subsidiary-nuvaila-will-offer-biosimilars-of-stelara-humira

2. Jeremias S. FDA approves first Stelara biosimilar, Wezlana. The Center for Biosimilars. November 1, 2023. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-stelara-biosimilar-wezlana

3. Jeremias S. FDA approves Steqeyma: the seventh Stelara biosimilar. The Center for Biosimilars. December 18, 2024. Accessed December 18, 2024. https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-the-seventh-stelara-biosimilar

4. Jeremias S. CMS announces new drug prices under the IRA, including for Stelara and Enbrel. The Center for Biosimilars. August 19, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/cms-announces-new-drug-prices-under-the-ira-including-for-stelara-and-enbrel

5. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars. May 29, 2023. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

6. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

7. Jeremias S. Report: varied biosimilar uptake speeds pose missed opportunities for cost savings. The Center for Biosimilars. January 23, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/report-varied-biosimilar-uptake-speeds-pose-missed-opportunities-for-cost-savings

8. Jeremias S. Samsung Bioepis report showcases adalimumab biosimilar growth in market share. The Center for Biosimilars. October 11, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/samsung-bioepis-report-showcases-adalimumab-biosimilar-growth-in-market-share

9. CVS to remove Humira from some reimbursement lists in favor of biosimilar options. The Center for Biosimilars. January 6, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/cvs-to-remove-humira-from-some-reimbursement-lists-in-favor-of-biosimilar-options

10. Santoro C. Jeffrey Casberg predicts generic, biosimilar competition in the pharmaceutical market. The Center for Biosimilars. May 12, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/jeffrey-casberg-predicts-generic-biosimilar-competition-in-the-pharmaceutical-market

11. Jeremias S. Skyrizi overtakes Humira: “product hopping” leaves biosimilar market in limbo. The Center for Biosimilars.November 7, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/skyrizi-overtakes-humira-product-hopping-leaves-biosimilar-market-in-limbo

12. Adolph N, Carden MJ, Sargent M. Humira biosimilar adoption: hints of progress or signs of doom? Presented at: GRx+Biosims; October 21-23, 2024; Rockville, MD.