On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows approval of the same induction regimen in the US one month earlier.  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).

On 16 October 2025, the CHMP announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to Tremfya® for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.  Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

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.

On 16 October 2025, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to J&J/Janssen’s Tremfya® (guselkumab).  The recommended extension is the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.  It has since received European approval for adults with moderately to severely active ulcerative colitis (April 2025) and for adults with moderately to severely active Crohn’s disease (May 2025).

The CHMP’s positive opinion 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.

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.

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 2025; UC, 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.

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®), in MENA (Middle East and North Africa).

Under the agreements, MS Pharma will be responsible for registration, marketing, and distribution across MENA, while Polpharma will maintain responsibility for development, manufacture and supply.  Both parties have agreed to transfer fill and finish activities to MS Pharma’s biologics manufacturing facility in Saudi Arabia.

In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

There are a number of other vedolizumab biosimilars in development, including by Intas (INTP53) and Alvotech (AVT16).

At least Sandoz (CYB704), Amgen (ABP 692) and Celltrion (CT-P53) have ocrelizumab biosimilars in development, while Alvotech is developing a guselkumab biosimilar which is to be commercialised in the EU, UK and Switzerland by Advanz Pharma.

On 28 August 2025, the UK’s NICE published guidance recommending J&J/Janssen’s Tremfya® (guselkumab) for use within England’s NHS for previously treated moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (UC).

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 2025; UC, April 2025) and the US (Crohn’s, March 2025; UC, September 2024).

In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 7 May 2025, Johnson & Johnson announced that the European Commission (EC) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows the recent EU approval of Tremfya® in April 2025 for the treatment of patients with moderately to severely active ulcerative colitis who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

In March 2025, Tremfya® was approved by the US FDA for adult patients with moderately to severely active Crohn’s disease.  Tremfya® is also approved in the US for a number of other indications, including for ulcerative colitis (September 2024) and plaque psoriasis (July 2017).

At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions, including to:

• BMS’ Opdivo® (nivolumab) in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo® as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression at or higher than 1%.
• Janssen’s Tremfya® (guselkumab) for treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment; and
• Beigene’s Tevimbra® (tislelizumab) in combination with etoposide and platinum chemotherapy, for first-line treatment of adults with extensive-stage SCLC.

The CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).  Subcutaneous Opdivo® has previously been approved in the US for most but not all previously approved adult, solid tumour indications.

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease.  According to J&J, Tremfya® is the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options.

Tremfya® is approved in the US for a number of indications, including for the treatment of adults with moderately to severely active ulcerative colitis (September 2024) and adults with plaque psoriasis (PsO) (July 2017).

In December 2024, J&J announced its submission to the FDA of two supplemental Biologics Licence Applications (sBLAs) for approval of Tremfya® for the treatment of children 6 years of age and older with moderate-to-severe PsO and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for an extended indication of Janssen’s Stelara® (ustekinumab) to children with Crohn’s disease weighing at least 40 kg.  The new indication will apply to Stelara® concentrate for solution for infusion and solution for injection in vial or pre-filled syringe.

Janssen also received positive CHMP opinions for Darzalex® (daratumumab), with the removal of a limitation that adult patients with newly diagnosed multiple myeloma to be treated must be “eligible for autologous stem cell transplant”, and Tremfya® (guselkumab), to include treatment of adults with ulcerative colitis.

AstraZeneca’s Imfinzi® (durvalumab) has received a positive recommendation for the new indication of treating adults with resectable NSCLC at high risk of recurrence.

The CHMP also adopted positive opinions for indication expansions to:

• Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), to include treatment of adults with unresectable or metastatic HR-positive HER2-low or -ultralow breast cancer; and
• Roche’s Columvi® (glofitamab), to include treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant.

In addition, after re-examining its initial opinion at MSD’s request, the CHMP confirmed its positive recommendation for an expanded indication for MSD’s Keytruda® (pembrolizumab) to include patients with unresectable non-epithelioid malignant pleural mesothelioma.  The positive recommendation was initially adopted in November 2024.