Stelara Biosimilars Undercut Medicare's Negotiated Price

A headline discount that the market already beat

When Medicare's first round of negotiated drug prices took effect on January 1, 2026, Johnson & Johnson's immunology blockbuster Stelara (ustekinumab) looked like one of the program's showcase wins. Its Maximum Fair Price (MFP) for a 30-day supply fell to $4,695 from $13,836, a 66% reduction. 1 Drug Channels likewise puts the MFP at 66% below Stelara's 2023 list price. 2

The problem for anyone treating that number as the story is that the market moved first. Nine Stelara biosimilars launched in 2025, some at discounts of up to 90% off the brand's list price. 1 Drug Channels reports that many of these competitors carry list prices 75% or more below Stelara's current wholesale acquisition cost. 2 In other words, a price that federal negotiators spent years extracting is already higher than what several rival versions of the same molecule charge.

What Stelara is, and why it was selected

Stelara treats plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis by blocking IL-12 and IL-23, two proteins that drive inflammation. 1 Outside Medicare, the 90 mg subcutaneous syringe has a retail list price of roughly $11,000 to $17,000 per injection. 1

It was one of ten drugs chosen for the first negotiation cycle under the Inflation Reduction Act of 2022, alongside Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica and NovoLog. 5 To qualify, a drug had to be a brand-name product without competition and among the biggest drivers of Medicare spending. 5 Medicare Rights Center says the negotiated prices are at least 38% off 2023 list prices and are projected to save beneficiaries $1.5 billion a year in out-of-pocket costs and Medicare $6 billion a year. 5

That "no competition" requirement explains the awkwardness. Stelara was picked in 2023, when it had no biosimilar rivals. 5 By the time its negotiated price arrived, it faced a crowded field. This looks less like a policy failure than a timing mismatch built into a multi-year process: a 2023 selection, 2024 price publication and 2026 effective date. 5 Given that eligibility hinges on the absence of competition, Stelara's place on the negotiated list appears increasingly hard to justify, and its time there may be short.

Who actually captures the savings

The biosimilar wave has not flowed straight to patients. Drug Channels' review of the three largest pharmacy benefit managers' 2026 formulary exclusions shows that preferred options for Stelara, as for Humira, are dominated by private-label biosimilars tied to the same parent companies that run those PBMs. 2 Many of the preferred products have lower list prices, which Drug Channels reads as a growing tension between the traditional rebate-driven formulary model and competition based on net price. 2

A third channel adds pressure from outside. Mark Cuban Cost Plus Drug Company sells the Stelara biosimilar Starjemza at a direct-to-patient price, showing how deep discounts can reach consumers without formularies, rebates or utilization management. 2 Drug Channels presents this as a threat to PBMs' control over what patients receive. 2

For patients, the practical upshot is mixed. Medicare enrollees get the $4,695 MFP. 1 Commercially insured patients may be steered toward a PBM-affiliated biosimilar, and uninsured patients may find a cash-price route cheaper than any negotiated figure. J&J's patient assistance programs remain another option for some. 1

The program is becoming permanent

Stelara's situation arrives as CMS formalizes the negotiation program. On June 12, 2026, the agency issued Proposed Rule CMS-4215-P, which would replace guidance-based administration with a permanent regulatory framework for cycles starting with the 2029 initial price applicability year. 34 Duane Morris notes that the rule would codify much of what CMS has handled through guidance, covering drug selection, MFP implementation, manufacturer obligations and Part D sponsor requirements. 3 Holland & Knight highlights proposed changes affecting fixed-combination products and small biotech products, along with expanded compliance, reporting and enforcement requirements for manufacturers. 4

In the meantime the list keeps growing. Fifteen more drugs, including Ozempic, get negotiated prices in 2027. 5

The takeaway

Stelara shows both sides of drug price negotiation. Negotiation delivered a large, guaranteed cut for Medicare beneficiaries on a drug that had no competition when it was selected. Biosimilar entry then did what it is supposed to do and undercut that price. For brands nearing loss of exclusivity, the market, not the MFP, may end up setting the real price. The harder question, which Drug Channels' formulary data raises sharply, is whether those market discounts reach patients or are absorbed by intermediaries. 2 As CMS writes permanent rules, how negotiation interacts with biosimilar timing deserves as much attention as the size of the headline discounts.