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.

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January.  Among the applications for new medicines to be reviewed is GSK’s Blenrep® (belantamab mafodotin) for the treatment of patients with multiple myeloma that has returned or did not respond to treatment.

Meanwhile, AbbVie’s Elahere® (mirvetuximab soravtansine) has been accepted for review for the treatment for adult patients with a specific type of ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.  Elahere® received EU approval for this indication in November 2024.

Applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

• AstraZeneca’s Imfinzi® (durvalumab) for muscle invasive bladder cancer. Imfinzi® is already also under review by the TGA for the treatment of patients with limited-stage small cell lung cancer;
• Takeda’s Adcetris® (brentuximab vedotin) for the treatment of adult patients with previously untreated Hodgkin Lymphoma, in combination with other anti-cancer drugs;
• Janssen’s Darzalex SC® (daratumumab) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for a stem cell transplant, and high-risk smouldering multiple myeloma; and
• Janssen’s Tremfya® (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis who are eligible for systemic (whole-body) therapy or phototherapy (ultraviolet light therapy.

On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  

The May 2025 agenda lists 8 biologics for consideration, 3 of which are listed for new PBS additions:  

New listing applications

• UCB’s Bimzelx® (bimekizumab) moderate to severe hidradenitis suppurativa
• AstraZeneca’s Imjudo® (durvalumab) in combination with tremelimumab for the first line treatment of patients with advanced (unresectable) Stage B Barcelona clinic liver cancer or Stage C hepatocellular carcinoma.
• Accelagen’s Briumvi® (ublituximab) for relapsing-remitting multiple sclerosis

Amendment applications

• GSK’s Jemperli® (dostarlimab) for use in combination with platinum-containing chemotherapy for the treatment of primary advanced or first recurrent mismatch repair proficient endometrial cancer
• Janssen’s Tremfya® (guselkumab) for severe chronic plaque psoriasis
• Novartis’ Xolair® (omalizumab) for CRSwNP
• Novartis’ Lucentis® (ranibizumab) for proliferative diabetic retinopathy
• AstraZeneca’s Enhertu® (trastuzumab deruxtecan) for gastric or gastroesophageal junction cancer

In November 2024, PBAC previously published its agenda for the March 2025 meeting, which will consider 23 monoclonal antibodies, including four biosimilars. 

On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications (sBLAs) to FDA for approval of Tremfya® (guselkumab) for the treatment of children 6 years of age and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).  These submissions come more than seven years after Tremfya® was approved for treating PsO in adults in the US, where it is also approved for PsA and ulcerative colitis in adults.

Tremfya® is approved in Europe and other countries for plaque psoriasis and active psoriatic arthritis.

On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).  The filing is supported by data from the Phase 3 ASTRO study (NCT05528510).

This follows the recent approval of Tremfya® in the US for UC, with an intravenous induction dose followed by subcutaneous maintenance (September 2024).  Tremfya® is also under consideration for approval for UC in Australia and Europe.

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October.

Among the new applications to be reviewed is Freyr’s new application for liraglutide (Lobezyl®).  This follows TGA acceptance of Cipla’s liraglutide for review in October 2023 and Sun Pharma’s in January 2024.  Novo Nordisk’s Saxenda® (liraglutide) was approved in Australia in 2015 for weight management.

Meanwhile, an application for a new indication for Novo Nordisk’s Ozempic® (semaglutide), for reducing risk of kidney failure, was accepted for review in September 2024.

Applications for new indications for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) have also been accepted for review (in October and September 2024, respectively), for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

AstraZeneca has two applications for expanded indications under review: Imfinzi® (durvalumab) for the treatment of patients with limited-stage small cell lung cancer; and Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with metastatic NSCLC or NSCLC that cannot be removed surgically.

Other applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

• Janssen’s Tremfya® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn’s disease;
• Eli Lilly’s Omvoh® (mirikizumab) for the treatment of ulcerative colitis in adults who have not benefited from conventional treatments; and
• Roche’s Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust” results in subcutaneous induction and maintenance therapy, demonstrating “significant” clinical remission and endoscopic response at 48 weeks.  Based on these results, J&J considers that guselkumab could become the first IL-23 treatment to offer both SC and IV induction options for Crohn’s disease.

In a separate Phase 3b study (SPECTREM), sponsored by J&J, Tremfya® was shown to result in clear or almost clear skin in the majority of patients with low body surface area moderate plaque psoriasis with special site involvement who had failed topical treatment.  These results were presented on 25 October at the 2024 Fall Clinical Dermatology Conference.

Tremfya® is approved in Europe, the USA and other countries for moderate to severe plaque psoriasis and active psoriatic arthritis.  Tremfya® received FDA approval in September 2024 for moderately to severely active ulcerative colitis.  J&J submitted applications for approval of Tremfya® for Crohn’s disease to the FDA in June 2024 and in Europe in May 2024.

Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Tremfya® is already approved in the US for adults with moderate-to-severe plaque psoriasis and with active psoriatic arthritis.  A further sBLA for Crohn’s Disease was submitted to the FDA in June 2024.

On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD).  The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in significant improvements on a number of endoscopic endpoints when compared to both Stelara® (ustekinumab) and placebo.

As previously reported, J&J is seeking EMA approval to expand its marketing authority for Tremfya® to include treatment of adult patients with moderate to severe UC and moderate to severe CD.