Johnson & Johnson's immunology franchise faces unprecedented challenges as Stelara (ustekinumab), the company's former blockbuster autoimmune drug, recorded a devastating 33.7% year-over-year sales decline to $1.08 billion in Q1 2025. The dramatic downturn reflects the mounting pressure from biosimilar competition that began flooding the market after Stelara's key patent expired in September 2023.
The sales collapse was geographically widespread, with U.S. sales dropping 29.8% and international sales plummeting 38.9%. This decline created an 810 basis point drag on J&J's Innovative Medicine segment growth, underscoring Stelara's strategic importance to the company's portfolio.
Biosimilar Onslaught Reshapes Market Dynamics
Eight ustekinumab biosimilars have launched in the U.S. market, including Amgen's Wezlana, Sandoz's Pyzchiva, and Biocon's Yesintek, offering substantial discounts of 46% to 90% versus Stelara's list price. The biosimilar landscape differs markedly from the Humira competition, with most ustekinumab biosimilars launching with list prices ranging from 80% to 90% below Stelara's pricing.
Pharmacy benefit managers have aggressively shifted formulary preferences toward biosimilars. According to MMIT research conducted in May 2025, the majority of surveyed payers and PBMs representing 83% of commercial lives indicated they were very or extremely likely to remove Stelara from their formularies by Q2 2026. These payers noted that biosimilars offer lower list prices, more favorable contracting, and greater cost savings for patients.
The three major PBMs have established private-label subsidiaries for biosimilar distribution: CVS Health's Cordavis, Cigna Group/Express Scripts' Quallent Pharmaceuticals, and UnitedHealth Group/Optum Rx's Nuvaila. These entities are following the same playbook used with Humira biosimilars, with Amgen partnering with Nuvaila to exclusively private-label Wezlana, while Cordavis commercializes a private-label version of Samsung Bioepis's Pyzchiva.
Legal and Regulatory Pressures Mount
J&J faces additional headwinds from a pending antitrust lawsuit accusing the company of unlawfully delaying biosimilar competition by acquiring patents fraudulently and settling lawsuits with competitors to push launch dates to 2025. If J&J loses this case, biosimilar adoption could accelerate further.
The Inflation Reduction Act adds another layer of complexity. Stelara was selected as one of the first ten products for Medicare Drug Price Negotiation Program, mandating a 66% price cut from its 2023 list price beginning January 1, 2026. However, uncertainty remains about whether this negotiated price will take effect, given that market competition may have already accomplished the program's cost-reduction goals.
J&J's Strategic Response
To offset Stelara's losses, J&J is pursuing multiple strategies. The company is advancing icotrokinra, a once-daily pill for psoriasis and Crohn's disease that could displace injectable therapies like Stelara. Additionally, J&J recently launched Tremfya (guselkumab) for Crohn's disease, positioning this biosimilar-resistant biologic to capture market share in the IL-23 targeting space.
The company has also introduced an unbranded ustekinumab product, following a similar strategy used in 2021 when it launched low-cost, unbranded infliximab after Remicade faced biosimilar competition.
Despite Stelara's decline, other J&J products are showing growth, with Tremfya sales increasing 18.2% and ERLEADA up 11.9%, providing some compensation for the immunology segment.
Market Outlook and Investment Implications
Experts predict adalimumab biosimilars will reach 60% market share by the end of 2027, having already captured approximately one-third of the market. The ustekinumab biosimilar trajectory may follow a similar pattern, particularly given that payers plan to place between one and four ustekinumab biosimilars on their preferred specialty tier.
For investors, J&J's diversified portfolio including oncology drugs like Darzalex and Carvykti, plus its $15 billion annual R&D budget, provides a safety net. However, if U.S. biosimilars capture more than 50% of Stelara's market by 2026, the company's immunology segment could face structural declines.
The biosimilar competition for Stelara represents more than just one drug's patent cliff—it signals a broader shift in how biologics are managed in an increasingly cost-conscious healthcare environment, with implications extending far beyond J&J's immediate portfolio challenges.
