On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab) label to include data demonstrating that the treatment inhibits the progression of structural joint damage in adults with active psoriatic arthritis (PsA). The label update positions Tremfya® as the only IL-23 inhibitor with demonstrated structural inhibition in its label, offering patients with active PsA a first-line treatment option that provides both symptom control and protection against irreversible joint damage.
Tremfya® was first approved in the US for moderate-to-severe plaque psoriasis (PsO) in July 2017. Since then, its approved indications have been significantly expanded: the FDA approved Tremfya® for moderately to severely active ulcerative colitis (UC) in September 2024, followed by approval of a subcutaneous induction regimen for UC in September 2025, and approval for moderately to severely active Crohn’s disease in March 2025. In September 2025, the FDA also extended Tremfya®’s PsO and PsA approvals to children aged six and older weighing at least 40 kg.
No guselkumab biosimilars have been approved in any major market, and biosimilar development of guselkumab appears to be at early stages globally. In September 2025, Polpharma Biologics and MS Pharma entered into a licensing agreement for the commercialisation of PB019 (biosimilar guselkumab) in the Middle East and North Africa (MENA) region. Alvotech has a proposed guselkumab biosimilar in development (partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland), and Samsung Bioepis announced in January 2026 that it has biosimilar guselkumab in development.