Are new medicines replacing Stelara?

Yes, the landscape is shifting significantly. Stelara (ustekinumab) is being challenged on two fronts simultaneously: newer, more selective biologics in the same drug class, and an influx of biosimilars offering the same molecule at lower cost.

Newer, more targeted biologics

Stelara works by blocking both IL-12 and IL-23 cytokines (via the p40 subunit). A newer generation of drugs targets only the IL-23 pathway (via the p19 subunit), which is thought to be the more disease-relevant driver of chronic inflammation. Three of these selective IL-23 inhibitors are now FDA-approved for inflammatory bowel disease (IBD) and/or psoriasis:

Drug (brand).................Manufacturer..................Approved Conditions
Risankizumab (Skyrizi).......AbbVie.........Crohn's, ulcerative colitis, plaque psoriasis, psoriatic arthritis
Mirikizumab (Omvoh)..........Lilly..........Crohn's (Jan 2025), ulcerative colitis
Guselkumab (Tremfya).........J&J............Crohn's (2025), ulcerative colitis, plaque psoriasis, psoriatic arthritis

Clinical trial data (the GALAXI and SEQUENCE studies) suggests risankizumab may be superior to ustekinumab in Crohn's disease, including in patients who have previously been on anti-TNF therapy. Skyrizi reached approximately $17.6 billion in 2025 global revenue, while Stelara's sales fell to around $6 billion — a dramatic reversal.

Beyond IL-23 inhibitors, other new options are also entering the IBD space, including the oral JAK inhibitor upadacitinib (Rinvoq) and the oral S1P modulators ozanimod (Zeposia) and etrasimod (Velsipity), offering patients non-injectable alternatives.

Biosimilars

Separately from the newer drugs, at least seven biosimilar versions of ustekinumab itself entered the U.S. market in 2025. These are not new mechanisms — they are copies of Stelara that are FDA-approved as interchangeable, meaning a pharmacist can substitute them without a new prescription in most states. Examples include Selarsdi (ustekinumab-aekn) and Yesintek (ustekinumab-kfce). These are aimed at reducing cost and expanding access rather than improving efficacy.

What this means in practice

Stelara isn't disappearing — it remains a widely used, effective treatment, and J&J even secured a new pediatric Crohn's approval for it in April 2026. But clinicians now have more choices. Which drug a patient uses increasingly depends on insurance coverage, prior treatment history, and physician preference rather than one drug being definitively better for all cases.

If you're currently on Stelara (or considering it), it's worth asking your specialist whether any of the newer selective IL-23 agents or biosimilar options might be appropriate for your situation.

✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦ ✦

paris.us