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New Indication Alert: FDA Approves J&J’s Subcutaneous Guselkumab for UC

Sep 19, 2025

On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).  The BLA for the SC regimen was accepted in November 2024 and followed the approval of Tremfya® with intravenous (IV) induction for UC in September 2024.

In March 2025, the FDA approved Tremfya® for the treatment of moderately to severely active Crohn’s disease in adults.  With the latest approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and IV induction options for the treatment of UC and Crohn’s disease in the US.

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease and UC in May 2025 and has been approved for the same indications in the EU (Crohn’s, May 2025UC, April 2025).

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 Middle East and North Africa (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.