Regulatory ImpactRegulatory Impact

FDA product evidence mapped to briefs, portfolios, and indication-target networks.

Regulatory InsightsResearch Brief

The Current IL-23 Product Landscape

Selective IL-23-pathway therapies now span skin, joints, bowel disease, biosimilar-exposed legacy products, and the first oral IL-23 receptor antagonist, creating a more segmented and strategically important market than the earlier psoriasis-only class.

Regulatory ImpactMay 14, 202618 min read
IL-23PsoriasisInflammatory bowel diseaseBiologicsCompetitive intelligenceImmunology
Brief summary

The IL-23 market has shifted from a small psoriasis subclass into a broad immunology platform that now includes bowel-disease blockbusters, active biosimilar disruption around ustekinumab, and the first approved oral IL-23 receptor antagonist. Commercial leadership is concentrated in Skyrizi, but clinical differentiation is now occurring on route, dosing convenience, bowel breadth, and payer economics as much as on mechanism alone.

Executive summary

As of 2026-05-14, the IL-23 landscape includes six approved branded pathway products in major markets: ustekinumab, guselkumab, risankizumab, tildrakizumab, mirikizumab, and icotrokinra. Mechanistically, that now spans IL-12/23 p40 blockade, selective IL-23p19 blockade, and direct oral IL-23 receptor antagonism. 1234

Commercially, AbbVie’s Skyrizi is the clear leader. Using public filings, Skyrizi reached about $17.56 billion in 2025 global revenue, compared with Johnson & Johnson’s 2025 sales of $6.08 billion for Stelara and $5.16 billion for Tremfya. Almirall reported €234.4 million of 2025 Ilumetri net sales in Europe. Lilly’s 2025 10-K did not separately disclose Omvoh product-level annual sales, and Icotyde is too new to have a meaningful full-year commercial base. 5462

Clinically, selective IL-23 blockade has become a core mechanism in plaque psoriasis and a rapidly strengthening option in Crohn’s disease and ulcerative colitis. Payer behavior, however, is unlikely to treat the class as homogeneous: ustekinumab is now a biosimilar-exposed legacy asset, while p19 antibodies and oral IL-23R blockade remain premium-positioned and are still differentiating on breadth, convenience, and evidence generation. 7489

Recent regulatory movement reinforces the direction of travel. The FDA approved Omvoh for Crohn’s disease in January 2025, Icotyde on March 17, 2026, as the first oral IL-23 receptor antagonist for plaque psoriasis, and Stelara for pediatric Crohn’s disease in April 2026. Those approvals collectively point toward broader bowel use, greater route flexibility, and deeper lifecycle management across the pathway. 10911