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.

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting, adopting positive opinions for the following nine biosimilars:

• Golimumab: Alvotech/Advanz Pharma’s Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab). In November 2024, Alvotech/Advanz Pharma’s European MAA for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world;
• Denosumab: STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, and Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) and Intas’ Denosumab Intas, biosimilar to Amgen’s Prolia® (denosumab);
• Ustekinumab: Bio-Thera/STADA’s Usgena™ (BAT2506), biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Bio-Thera and STADA entered an exclusive commercialisation agreement in relation to BAT2506 in May 2024 under which Bio-Thera has responsibility for development and manufacturing the biosimilar while STADA has exclusive commercialisation rights in the EU, UK, Switzerland and certain other countries.

There are currently 8 sponsors with denosumab biosimilars approved in Europe although none have launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025.

There are no golimumab biosimilars approved in the EU, so Alvotech is likely to have the first EU approved biosimilar golimumab.  Following acceptance of Alvotech/Advanz’s MAA for AVT05 in November 2024, Bio-Thera/STADA’s MAA for BAT2506 was accepted by the EMA in February 2025.

There are a number of ustekinumab biosimilars now marketed in EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in 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 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan will end 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 will exclusively handle 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.

This news follows a series of recent announcements by biosimilar competitors relating to the launch of ustekinumab in Japan, including:

• Celltrion’s launch of Steqeyma® (CT-P43), biosimilar to Stelara®, in Japan on 8 July 2025.
• Samsung Bioepis’ partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Stelara®.
• Biocon Biologics’ May 2025 announcement that Yoshindo, its commercial partner, launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic arthritis.

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent), ruling that the method of treatment patent is valid.  The Janssen Patent relates to the use of ustekinumab in the treatment of ulcerative colitis (UC).

Samsung Bioepis had challenged the validity of the Janssen Patent on the grounds of lack of novelty and lack of inventive step.  However, the challenge failed on both grounds, with the Dutch court upholding the validity of the Janssen Patent and ordering Samsung Bioepis to pay Janssen’s costs of the proceeding, estimated to date to be €190,000.  Samsung Bioepis has appealed the judgment.

Samsung Bioepis’ court action is the latest in a series of court actions in The Netherlands, including a case pending in the Dutch Supreme Court regarding an SPC waiver for producing a Stelara® biosimilar for export to third countries.  The Supreme Court hearing date is yet to be published.

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

• 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 UC, 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 invalidate Janssen’s CA Patent 3,113,837 for 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.
• Australia: On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024.  The Janssen innovation patents all related to a method of treating UC with ustekinumab.
• 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 for treating UC.

On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia, biosimilars to J&J/Janssen’s Stelara® and Novartis’ Xolair®, respectively.  On 1 August 2025, Arrotex announced its strategic licensing agreement with Celltrion for the Australian commercialisation of Celltrion’s ustekinumab and omalizumab biosimilars.

The Arrotex announcement came on the same day that Steqeyma® became the first ustekinumab biosimilar to be PBS-listed (1 August 2025).  Although Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  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”.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in pre-filled syringe (PFS) presentations in November 2024 and was (together with Steqeyma®) PBS-listed on 1 August 2025.  In August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Omlyclo® in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).