On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in children aged six and older, weighing at least 40 kg. J&J submitted the two supplemental Biologics Licence Applications (sBLAs) for these indications in December 2024.
Tremfya® was first approved in the US for PsO (in adults) in July 2017. Earlier in September 2025, the FDA approved a subcutaneous induction regimen of Tremfya® for the treatment of adults with moderately to severely active ulcerative colitis (UC). This followed the approval of an intravenous (IV) induction regimen for UC in September 2024.
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.