Janssen's Stelara loses exclusivity with biosimilar launch, faces market defense challenge.
Original Blockbuster: Regulatory Status and Target Mechanism
Stelara (active ingredient: ustekinumab), developed by Janssen Biotech, a subsidiary of Johnson & Johnson (J&J), is a human monoclonal antibody therapy that targets the p40 subunit of interleukin-12 and -23 (IL-12/IL-23). The drug was first approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of plaque psoriasis and has since expanded its indications to include active psoriatic arthritis, Crohn's disease, and ulcerative colitis. Regulatory authorities' management of the BLA 125261 database serves as a key benchmark for tracking the safety profile and label updates of this blockbuster drug in real-time.
Biosimilar Tsunami and the Aftermath of Exclusivity Expiration
Stelara has long defended its market exclusivity through a layered patent strategy ('Patent Thicket'), but recent patent settlements have dramatically altered the market landscape. Following Amgen's Wezlana (active ingredient: ustekinumab-auub) receiving FDA approval as the first 'Interchangeable' biosimilar in October 2023, it was officially launched in the U.S. market on January 1, 2025. This was followed by a wave of subsequent biosimilars, including Selarsdi from Alvotech and Pyzchiva from Samsung Bioepis, effectively ending the original drug's exclusive market position.
Global Sales Decline and Intensified Price Competition
Stelara's global sales peaked at approximately $10.9 billion in 2023, but with the pressure of biosimilar launches and demands for price reductions, sales fell slightly to about $10.4 billion in 2024. With full-fledged competition beginning in 2025, new entrants are offering discounts of up to 80-90% off wholesale prices to gain market share. As a result, Johnson & Johnson is inevitably facing a decline in sales as it must offer substantial rebates to maintain its formulary status.
Transition to Next-Generation Pipeline and the Future of the Autoimmune Market
To offset the revenue loss from Stelara's patent expiration ('Loss of Exclusivity'), Johnson & Johnson is accelerating the transition to next-generation pipelines, such as Tremfya (active ingredient: guselkumab), an IL-23 selective inhibitor. From the perspective of patients and healthcare professionals, this provides a wider range of choices, including more affordable biosimilars and new drugs with higher target selectivity. As pharmacy benefit managers (PBMs) compete to list their preferred drugs, it is important to watch how the autoimmune disease market will be reshaped in the future.
The 2025 patent expiration of Stelara, a blockbuster drug with annual sales of $10.9 billion that has already received marketing approval, and the entry of biosimilars, marks a turning point in the competitive landscape of the autoimmune disease treatment market. With Amgen's first interchangeable biosimilar, Wezlana, and several other competing products entering the market simultaneously at discounts of up to 80-90% off wholesale prices, the decline in market share of the original product is expected to accelerate. From an investor's perspective, a key factor in Johnson & Johnson's (JNJ) mid- to long-term performance will be whether it can successfully transition prescriptions to new pipelines, such as the IL-23 inhibitor Tremfya, to offset the revenue loss from Stelara. For researchers and industry professionals, the inclusion of preferred drugs by pharmacy benefit managers (PBMs) and the scope of coverage benefits will be key regulatory and commercial factors in determining the initial market penetration of products.
Source: openFDA (api_fda)
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA125261