On 19 December 2025, Johnson & Johnson announced that the European Commission has approved an indication extension for Tremfya® (guselkumab) as a subcutaneous treatment for moderate to severe plaque psoriasis (Pso) in children and adolescents aged six and older who are candidates for systemic therapy.
Tremfya® is already approved in Europe for a number of indications, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients, adults with moderately to severely active ulcerative colitis (April 2025) and adults with moderately to severely active Crohn’s disease (May 2025).
The indication extension in Europe follows the FDA’s September 2025 approval of a Tremfya® paediatric indication extension for the treatment of severe plaque psoriasis and active psoriatic arthritis in children aged six years and older weighing at least 40 kg.
Biosimilar development of guselkumab is underway. In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region. In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.