On 25 March 2026, the Australian Pharmaceutical Benefits Assessment Committee (PBAC) published the agenda for its July 2026 meeting, with three biosimilars submitted for consideration.

One of the biosimilars will be considered for the first time, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), which will be supplied by its local partner Generic Health.  Yesintek® has not yet received Australian marketing approval but has been approved in other regions, including Europe (February 2025), the US (February 2025) and Canada (October 2025).

Celltrion’s Steqeyma®, which was the first ustekinumab biosimilar to be PBS listed in August 2025, has been submitted for consideration by PBAC in new forms (Injection 45 mg in 0.5 mL vial, Injection 45 mg in 0.5 mL single use pre-filled pen, and Injection 90 mg in 1 mL single use pre-filled pen).

In addition, Celltrion has submitted four new indications for Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), being: branch retinal vein occlusion with macular oedema; central retinal vein occlusion with macular oedema; diabetic macular oedema; and subfoveal choroidal neovascularisation due to age-related macular degeneration.  Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV).  It was recommended for PBS listing in November 2025 for the same indication.

On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab).  This approval enables Celltrion to launch two additional autoinjector formulations (45mg/0.5mL and 90mg/1.0mL) in Canada.

Canada has seen significant biosimilar activity for ustekinumab.  The following products have already been approved by Health Canada:

The US market has seen an even bigger wave of ustekinumab biosimilar activity in 2025.  By the end of the year, the FDA had approved a total of eight ustekinumab biosimilars.  The following biosimilars launched in the US during 2025:

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for 6 medicines, 3 of which are biopharmaceuticals: Sanofi/Regeneron’s Dupixent®, MSD’s Keytruda® and Janssen’s Stelara®.

Sanofi/Regeneron’s Dupixent® (dupilumab) received a positive recommendation for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU).  The existing CSU indication in Europe (approved in November 2025) covers adults and adolescents (12 years and above).  According to Regeneron’s press release, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

The CHMP also recommended indication of MSD’s Keytruda® (pembrolizumab), in combination with paclitaxel (with/without bevacizumab), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in certain adults.

Janssen’s Stelara® (ustekinumab) received a recommendation for a change to its indication for paediatric Crohn’s disease for children from 2 years of age, from the current indication of paediatric patients weighing at least 40 kg.

Biosimilar launches, approvals and/or development are well underway for each of dupilumab, pembrolizumab and ustekinumab:

• Companies with dupilumab biosimilars in development include Alvotech, Samsung Bioepis, Formycon, Mabwell, Chong Kun Dang. CSPC Pharmaceutical, and Bio-Thera Solutions.
• Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.
• Ustekinumab biosimilars were launched in Europe in July 2024 by STADA/Alvotech (Uzpruvo®) and Sandoz (Pyzchiva®). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) updated its March 2026 agenda (first published in November 2025) to include consideration for reimbursement of Amgen’s Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab).

In April 2024, the PBAC recommended  Wezlana® for listing on the Pharmaceutical Benefits Scheme (PBS).  However, Amgen did not proceed with the listing at that time.  Amgen has now come back to the PBAC for consideration of PBS listing of Wezlana® in March 2026.

Wezlana® joins Sandoz’s ustekinumab biosimilar, Ardelya®, on the March 2026 PBAC Agenda, although Ardelya® has not yet received marketing approval in Australia.  Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval from Health Canada.

Imuldosa® has already been launched in 19 countries, including the UK and Ireland (April 2025) and the US (August 2025).  It has also obtained marketing approval in the Middle East and North Africa region, including Saudi Arabia, Qatar, and the United Arab Emirates.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.  Intas is commercialising Imuldosa® through its global affiliates, including Accord BioPharma in the US and Accord Healthcare in Europe, the UK, and Canada.

A number of ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024), Fresenius’ Otulfi® (approved December 2024, launched May 2025) and Biocon’s Yesintek™ (approved October 2025).

On 14 January 2026, Samsung Bioepis announced that Korea’s Ministry of Food and Drug Safety has approved a pre-filled pen formulation (PFP) of Epyztek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  According to Samsung Bioepis, this is the first PFP presentation of ustekinumab to be approved in Korea.

Epyztek® (SB17) was the first ustekinumab biosimilar approved in South Korea in April 2024.  SB17 was approved in Europe in April 2024 as Pyzchiva® and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.  In the US, Pyzchiva® was approved in July 2024 and launched in February 2025, in PFS and vial forms.  Under a development and commercialisation agreement with Sandoz entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.

The EMA’s CHMP adopted a positive opinion for Celltrion’s PFP/autoinjector presentation of its ustekinumab biosimilars, Steqeyma® and Qoyvolma®, in December 2025.  Celltrion’s PFP presentation of the product was approved in Australia in the same month.

On 6 January 2026, Fresenius Kabi announced that it has introduced a new presentation of Otulfi®, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab), in a 45 mg/0.5 mL single-dose vial for subcutaneous injection.

Following the introduction of this new presentation, Fresenius Kabi now offers all dosage forms and strengths of Stelara®, with Fresenius Kabi’s Otulfi® also having received interchangeability designation from the FDA in May 2025.

Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling the US launch of Otulfi® in March 2025.

There are a number of other ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

On 27 December 2025, Medical Dialogues reported that Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ, had terminated its agreement with US-based BioFactura Inc regarding BFI-751, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab).  The termination is said to have been by consent and to have followed a strategic review of CuraTeQ’s portfolio prioritisation efforts.

Under the agreement before its termination, CuraTeQ had global manufacturing rights and an exclusive licence to commercialise BFI-751, in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ.

CuraTeQ remains actively involved in the development of biosimilars, announcing positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab) in September 2025.  According to that announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.  Earlier in July 2025, The Economic Times reported that CuraTeq had received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

On 23 December 2025,  Samsung Bioepis announced that it has received marketing approval in Japan for Nipro™, biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab).  Nipro™ delivers ustekinumab in a subcutaneous 45mg injection, and is the first product to gain marketing approval in Japan under the June 2025 partnership between Samsung Bioepis and Nipro Corporation.

Nipro™ has been approved for the treatment of plaque psoriasis and psoriatic arthritis and is expected to become commercially available following its listing on Japan’s National Health Insurance drug list in May 2026.

Samsung Bioepis’ announcement follows First Word Pharma’s report in September 2025 that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan ended on 31 December 2025.  Under the co-promotion agreement, MTPC has been responsible for distribution of Stelara® in Japan, with both MTPC and Janssen jointly conducting promotion of Stelara® to healthcare professionals.  After 31 December 2025, Janssen exclusively handles the sales, distribution, and information provision activities for Stelara® in Japan, with MTPC continuing the distribution of Stelara® bearing the MTPC name until the inventory is depleted.

Samsung Bioepis is one of a number of biosimilar competitors launching ustekinumab products in Japan, including, Celltrion (July 2025) and Biocon Biologics (May 2025).

On 18 December 2025, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an autoinjector (pre-filled pen) form of Steqeyma® and Qoyvolma®, biosimilars to J&J/Janssen’s Stelara® (ustekinumab).  The CHMP also recommended Qoyvolma® for a 45 mg vial formulation, such that Celltrion will have a “full lineup” of both products with all dosages and formulations of Stelara®.

According to Celltrion, the autoinjector device includes a viewing window and audible indicators to enable patients to easily identify the injection status and has “special thin-wall needle technology to help reduce injection pain”.

The positive EU opinion for the autoinjector presentation of Celltrion’s ustekinumab biosimilars, comes just days after Celltrion received approval for the same presentation of Steqeyma® in Australia.

Steqeyma® was first approved in the EU in September 2024 in a pre-filled syringe (45mg/0.5mL, 90mg/1mL) and vial (45mg/0.5mL) for subcutaneous injection, as well as 130mg/26mL concentrate for intravenous infusion.  It was launched in the EU in November 2024 and is indicated for adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.  Qoyvolma® received EU marketing approval in June 2025, with an additional indication to that of Steqyema®, being moderately to severely active ulcerative colitis in adults.

Ustekinumab biosimilars already being commercialised in Europe include STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva®, both launched in July 2024.  Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).