On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
This follows the recommendation of the National Institute for Health and Care Excellence (NICE) in August 2025 for use within the UK’s NHS.
Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease (IV and SC) and UC (IV) in May 2025, and has been approved for the same indications in the EU (Crohn’s (IV and SC), May 2025; UC (IV), April 2025). In October 2025, the European Commission approved a SC dosage regimen for UC.
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.