On 14 April 2026, the US Court of Appeals for the Third Circuit published its judgment confirming the District Court’s decision to refuse to grant a preliminary injunction to prevent Samsung Bioepis from supplying its biosimilar ustekinumab to Cigna’s Quallent.

The decision arises from a complaint filed by Johnson & Johnson/Janssen in the US District Court for the District of New Jersey on 24 February 2025 alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023).  The agreement permitted Samsung Bioepis to launch Pyzchiva®/SB17 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  In November 2024, Samsung Bioepis entered into a Private Label Distributor (PLD) Agreement with Quallent Pharmaceuticals Health LLC, a subsidiary of the Cigna Group.  J&J/Janssen alleged that the sublicence to Quallent breached the settlement agreement and Janssen filed a motion for a preliminary injunction to prevent Samsung from supplying Quallent or authorising Quallent to distribute SB17 while the litigation was pending.

The US District Court refused to grant a preliminary injunction on the basis that Janssen had failed to establish that it would suffer irreparable harm if the injunction was not granted.  The Appeals Court found no error in that decision.  J&J/Janssen’s underlying breach of contract case remains ongoing.

Pyzchiva® was launched in the US by Sandoz in February 2025 (in PFS and vial forms), under a September 2023 development and commercialisation agreement with Samsung Bioepis.  That agreement gives Sandoz the right to commercialise Pyzchiva® in the US, as well as Europe, Switzerland, the UK and Brazil.  Pyzchiva® was launched in Europe in July 2024 and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.

J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (Steqeyma® launched March 2025), and Fresenius Kabi and Formycon (Otulfi® launched March 2025).  Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (launched August 2025) and Bio-Thera/Hikma’s Starjemza™ (launched November 2025).

On 9 April 2026, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), was approved in Australia in the following forms:

• 45 mg/0.5 mL solution for injection vial;
• 90 mg/1 mL solution for injection pre-filled syringe;
• 45 mg/0.5 mL solution for injection pre-filled syringe; and
• 130 mg/26 mL solution for intravenous infusion injection vial.

Yesintek® is manufactured by Biocon and is to be supplied in Australia by its local partner Generic Health.  Maxx Pharma Pty Ltd is the sponsor listed on the Australian Register of Therapeutic Goods (ARTG).

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) is due to consider Yesintek® for listing on the Pharmaceutical Benefits Scheme (PBS) at its July 2026 meeting.

Yesintek® joins a growing number of ustekinumab biosimilars approved in Australia, including Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024), Celltrion’s Steqeyma® (first approved September 2024), Samsung Bioepis’ Epyztek® (October 2024) and Alvotech/Cipla’s Uteknix® (February 2025).  To date, Celltrion’s Steqeyma® is the only ustekinumab biosimilar listed on the PBS (from 1 August 2025), with other ustekinumab biosimilars at varying stages of the PBAC approval process.

Yesintek® is approved in the US (December 2024), Japan (January 2025), Europe (February 2025), the UK (May 2025) and Canada (October 2025).

In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting from March 2026”.

Gedeon Richter is commercialising the ustekinumab biosimilar in Europe under a licence and commercialisation agreement entered into with Bio-Thera in October 2024.  Under the agreement, Bio-Thera is responsible for the development and manufacture of BAT2206 (ustekinumab), while Richter has commercialisation rights for the EU, UK and Switzerland.

BAT2206 was approved in the EU in August 2025 (as Usymro®), following a positive CHMP opinion in June 2025.

There are a number of ustekinumab biosimilars now marketed in the EU, including STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® (both launched in July 2024) and Celltrion’s Steqeyma® (launched November 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).

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).