Tuesday, July 08, 2025

The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market

The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.

Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest.

In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what’s changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes.

As always, with great pricing power comes great responsibility. Excelsior!

THE 2025 STELARA BIOSIMILAR MULTIVERSE

For 2025, biosimilars of Johnson & Johnson’s Stelara have been the biggest biosimilar launches for pharmacy benefits. Drug Channels previously covered the Stelara market in January’s The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars.

In addition to the Stelara reference product, there are now nine biosimilar versions of ustekinumab in the U.S. market plus one unbranded biologic offered by Johnson & Johnson. The products have list price discounts that are 5% to 90% lower than Stelara’s list price. Here are some quick facts about the market:
  • Despite interchangeability, nearly all of the Stelara biosimilars have proprietary brand names that are distinct from the original reference product’s brand name. These products are marketed as brand alternatives rather than as unbranded generics.
A STICKY WEB OF FORMULARIES

The table below summarizes the July 2025 formulary status for the 11 ustekinumab products along with wholesale acquisition cost (WAC) list prices. As a reminder, the WAC list price does not represent the price paid by any entity within the drug channel, because it excludes rebates and such other reductions as distribution fees, product returns, discounts to hospitals, price reductions from the 340B Drug Pricing Program, and other purchase discounts.

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All three PBMs’ formulary strategies for Stelara differ from the launch of Humira biosimilars, which predated fully-developed private label businesses.
  • Express Scripts. As of July 2025, Express Scripts’ National Preferred Formulary Exclusions now includes four products with varying list prices:
    • Stelara
    • An unbranded private label product from Quallent with a list price that’s only 46% below the reference product
    • Two branded biosimilars with list prices that are 86% and 90% below the reference product
    Quallent Pharmaceuticals is a subsidiary of Cigna’s Evernorth business, which also operates Express Scripts. Quallent's two Humira biosimilars on the Express Script formulary are also priced at a 46% discount to Humira.

    Last September, Evernorth announced that its Quallent biosimilar would be priced at a 90% discount to Stelara. I’ve not been able to determine why the actual discount was reduced to only 46%. (The Cigna PR team chose to ignore my emails requesting comment or clarification.)
  • Optum Rx. As we discussed in our January 2025 formulary analysis, Amgen launched its Wezlana biosimilar exclusively with Optum Rx with Nuvaila private label branding. Nuvaila is a subsidiary of UnitedHealth Group’s Optum segment, which also includes Optum Rx. As of January 2025, the Optum Rx formulary included three products: Stelara, Wezlana for Nuvaila (high list price), and Wezlana for Nuvaila (low list price).

    Effective July 1, 2025, however, Optum Rx excluded Stelara from its Premium Value and Premium Standard formularies in favor of both versions of Wezlana for Nuvaila. Optum Rx’s Select Standard formulary still includes Stelara as a tier 3 option with prior authorization.

    Notably, Optum Rx has also excluded Humira in favor of the low-list-price Amjevita for Nuvaila and the high-list-price Amjevita for Amgen biosimilars.

    Thus, Optum Rx’s main formulary will try to pop the bubble with its low-list-price private label products—but simultaneously lean into the gross-to-net bubble with high-list-price biosimilars. Even if net prices are comparable, it remains to be seen how many plan sponsors will resist the allure of rebates tied to the higher-priced biosimilar.
  • Other PBMs. Smaller PBMs have also embraced Stelara biosimilars while retaining the reference product on their formularies:
    • Prime Therapeutics’ PrimeChoice Accord Formulary includes Stelara along with three low-list-price biosimilars. Prime Therapeutics includes Wezlana on a non-preferred tier with prior authorization on its Accord formulary.
    One notable exception is Navitus Health Solutions, which has excluded Stelara in favor of ustekinumab-aekn, Steqeyma, and Yesintek. Teva’s unbranded ustekinumab-aekn is available via Navitus’ Lumicera Health Services specialty pharmacy. Unlike the biosimilars offered by the Big Three PBMs, this product is not a private label version, because it still uses Teva’s labeler code.
As an aside: PCMA recently claimed that "drug companies are solely responsible for setting and raising drug prices." That's misleading and not quite accurate. But it does raise an interesting question: who, exactly, sets the prices for products marketed by Cordavis, Nuvaila, and Quallent?

GREAT POWER

Stelara is also one of the 10 products chosen by CMS for negotiation under the Inflation Reduction Act. For 2026, the maximum fair price (MFP) for Stelara will be 66% below its 2023 list price.

In its June 2023 final guidance, CMS stated that it will monitor “whether meaningful competition continues to exist in the market by ongoing assessments of whether the manufacturer of the generic drug or biosimilar is engaging in bona fide marketing.” CMS has stated this monitoring will encompass multiple activities, including whether the biosimilar is “regularly and consistently available for purchase through the pharmaceutical supply chain,” market data, government price reporting, and other sources.

GREAT RESPONSIBILITY

The Stelara biosimilar market is shaping up to be a case study in how PBMs harness vertical integration, private label branding, and gross-to-net gamesmanship to drive their economic strategies. Unlike previous biosimilar waves, the Big Three PBMs entered this market with pre-built tools: house brands, formulary control, and contracting leverage.

It’s also clear that the IRA’s government-set prices will collide with real-world competitive dynamics. The PBM-driven formulary competition will surely qualify as meaningful competition—even if the competitors are, in many ways, just pointing at each other. It’s hard to imagine CMS proceeding with its scheduled 2026 price adjustment for Stelara. Like it or not, markets often beat government price setting.

But in the drug channel, no one swings alone. The largest PBMs are driving biosimilar adoption and popping the gross-to-net bubble—because they can profit from the switch. Will plan sponsors embrace the lowest net-cost products? Will rebate-rich high-list-price versions persist? Will CMS consider this true competition?

Stay tuned to your friendly neighborhood blogger for the answers!

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