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).

On 16 December 2025, the Australian Therapeutic Goods Administration (TGA) approved Celltrion’s Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two pre-filled pen (PFP) formulations:

• 90 mg/1 mL solution for injection pre-filled pen (500305); and
• 45 mg/0.5 mL solution for injection pre-filled pen (500306). 

Steqeyma® was first approved in Australia in September 2024 for the same strengths in pre-filled syringe presentations, as well as a 130 mg/26 ml concentrate in vial.  In August 2025, Steqeyma® became the first ustekinumab biosimilar to be PBS listed, and was subsequently launched in September 2025.

There are four other ustekinumab biosimilars approved in Australia: Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024), Samsung Bioepis’ Epyztek® (October 2024) and Alvotech/Cipla’s Uteknix® (February 2025).

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial formularies, including National Preferred Formulary, starting 5 September 2025.  Express Scripts is one of the United States’ largest pharmacy benefit managers.  Accord’s announcement follows the commercial launch of Imuldosa® in the US in August 2025.

Imuldosa® was FDA-approved in October 2024.  It was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord’s parent company) exclusive licensing rights worldwide, excluding certain Asian countries, in an agreement announced in 2021.  Under the agreement, Accord is responsible for US commercialisation.

There are a number of 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), Formycon/Fresenius Kabi’s Otulfi® (March 2025), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; and
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.

Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025.  In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).

In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025.  The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, 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 6 November 2025, Hikma Pharmaceuticals announced its US launch of Starjemza™, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  This is the first biosimilar Hikma has launched in the US.

Starjemza™ was approved by the FDA in May 2025.  It is commercialised in the US by Hikma under an exclusive commercialisation and licence agreement with Bio-Thera entered in August 2021.  Bio-Thera remains responsible for the development and manufacture of the product.

Other ustekinumab biosimilars launched in the US to date are: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025) and Celltrion’s Steqeyma® (March 2025).

On 6 November 2025, Samsung Bioepis announced that it has signed a settlement and licence agreement with Johnson & Johnson (J&J) in relation to the European commercialisation of Pyzchiva® (SB17), biosimilar to Stelara® (ustekinumab).

While the terms of the agreement are confidential, the settlement is expected to resolve a pending Dutch Supreme Court appeal in relation to Janssen’s Supplementary Protection Certificate (SPC) for EP 1 309 692 B1 regarding ustekinumab.  The appeal followed an April 2025 SPC Waiver ruling of the Hague Court of Appeal upholding an earlier decision that Samsung Bioepis did not infringe the SPC by manufacturing and stockpiling Pyzchiva® for export outside the European Union.

The parties have been involved in a number of disputes regarding the validity of Janssen’s European patents for ustekinumab, including EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis.  In September 2025, the District Court of The Hague held that the Dutch equivalent of the patent was valid.  A year earlier, in September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from an earlier decision that the UK counterpart of the patent was invalid.  Samsung Bioepis’ opposition to EP 3883606 in the European Patent Office was discontinued on 3 November 2025, after Samsung Bioepis formally withdrew it.

Pyzchiva® is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.  Pyzchiva® was approved by the European Commission in April 2024, and was launched by Sandoz in Europe in July 2024.

Samsung Bioepis and J&J settled US litigation regarding ustekinumab in 2023, permitting Samsung Bioepis/Sandoz to commercialise Pyzchiva® in the US in February 2025.

On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Canada, Japan (approved January 2025), Europe (approved February 2025) and the United Kingdom (approved May 2025) from an unknown date.  Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.

A number of other 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, not yet launched) and Fresenius’ Otulfi® (approved December 2024, launched May 2025).

On 9 October 2025, New Zealand’s Medsafe approved Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in vial and pre-filled syringe presentations, making Steqeyma® the first ustekinumab biosimilar approved in New Zealand.

Celltrion’s Steqeyma® has been approved and launched in a number of regions, including Korea (approved June 2024), Canada (approved July 2024, launched August 2024), the EU (approved September 2024, launched November 2024), the UK (approved September 2024, launched December 2024), Australia (approved September 2024, launched September 2025), the US (approved December 2024, launched March 2025), and Japan (approved March 2025, launched July 2025).

In August 2025, Steqeyma® became the first ustekinumab biosimilar to be listed on Australia’s Pharmaceutical Benefits Scheme (PBS).

On 3 October 2025, Pharmacy Times reported that CSPC Pharmaceutical Group’s SYSA1902 has been shown in a phase 3 study to be clinically equivalent to its reference product, Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis.

The results of the phase 3 study were published in the Journal of the American Academy of Dermatology in April 2025.  The results are likely to form the basis for an FDA approval application.

The phase 3 study follows CSPC’s November 2024 announcement that its biologic license application for ustekinumab was accepted by the People’s Republic of China’s National Medical Products Administration.  CSPC’s ustekinumab biosimilar was developed by related company CSPC Megalith Biopharmaceuticals.

On 3 October 2025, IP Australia delivered its decision in Samsung Bioepis’ opposition to the grant of Janssen’s AU2019346134 relating to a method of treating ulcerative colitis with Stelara® (ustekinumab).  IP Australia ruled that the patent application was invalid for lack of novelty and inventive step in light of prior art, including a clinical trial record.  Samsung Bioepis was unsuccessful on its third opposition ground, lack of support.

Janssen now has until 24 October 2025 by which to appeal the opposition decision to the Federal Court of Australia.  IP Australia has also given Janssen until 3 December 2025 to propose amendments to seek to overcome the deficiencies in the claims.

The IP Australia decision marks yet another success for Samsung Bioepis in its Australian litigation against Janssen regarding Janssen’s Australian ustekinumab patent portfolio for the treatment of ulcerative colitis.  On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042).  The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

The Australian ustekinumab legal actions are part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having claimed victory in other key jurisdictions including:

• The Netherlands: the District Court of The Hague delivered its judgment in September 2025 in Samsung Bioepis’ revocation action against EP 3 883 606, finding that the patent is valid.
• UK: In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis, was invalid.
• Canada: On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings. Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.
• EU: In April 2025, Samsung Bioepis successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
• US: On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar. J&J filed an appeal on 30 April 2025.
• Switzerland: The Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606. Janssen’s patent relates to the use of ustekinumab (the active ingredient in Stelara®) in the treatment of ulcerative colitis.