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).

On 26 and 27 August 2025, Bio-Thera Solutions and Gedeon Richter announced that the European Commission (EC) has approved BAT2206, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The approval follows the European Medicine Agency’s CHMP positive opinion for the biosimilar on 20 June 2025.

BAT2206 will be commercialised in Europe by Gedeon Richter under the brand name Usymro® subject to a licence and commercialisation agreement entered into with Bio-Thera for Usymro®/BAT2206 in October 2024.  Bio-Thera is responsible for the development and manufacture and Gedeon Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it will be commercialised by Hikma under the name Starjemza®.

There are a number of ustekinumab biosimilars now marketed in the 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 18 August 2025, MedImpact Holdings Inc. announced that, from 1 January 2026, Teva subsidiary Anda’s unbranded ustekinumab-aekn (biosimilar to J&J/Janssen’s Stelara®) will be available for direct purchase from MedImpact’s preferred partner, Birdi, Inc., by any licensed specialty pharmacy.

Separately, CivicaScript announced earlier this month that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz in the US from 1 January 2026.

MedImpact’s announcement follows Alvotech’s and Teva’s announcement in May 2025 that the FDA had approved Selarsdi® as interchangeable with Stelara® in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

Selarsdi® was the second ustekinumab biosimilar launched in the US, in February 2025, following a settlement between Alvotech/Teva and J&J entered in June 2023, which permitted the US launch of the biosimilar from 21 February 2025.  Other ustekinumab biosimilars that have been launched in the US to date are: Amgen’s Wezlana® (January 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).

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

On 18 August 2025, Accord BioPharma announced the US commercial launch of Imuldosa® PFS, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The Imuldosa® syringes are to be supplied at the lowest wholesaler acquisition cost (WAC) price among branded ustekinumab biosimilars.

Imuldosa® (DMB-3115) was FDA-approved in October 2024.  It was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord BioPharma’s parent company) exclusive licensing rights worldwide, excluding certain Asian countries, in an agreement announced in 2021.  Under the agreement, Accord BioPharma 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) and Celltrion’s Steqeyma® (March 2025).

On 12 August 2025, Celltrion announced that it has been awarded a series of supply contracts in Italy for its autoimmune disease therapies and oncology treatments.  Key contracts include additional contracts for Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in the Veneto, Trentino-Alto Adige, and Sardinia regions, following contracts for four regions earlier this year.  This means that Celltrion will now supply Steqeyma® to seven regions in total through to May 2026.

Steqeyma® was approved in Europe in August 2024, following a positive CHMP opinion in June 2024.  Celltrion launched Steqeyma® in Italy in mid-January 2025, with Celltrion confirming on 23 January 2025 that it had completed the launch of Steqeyma® in Italy, France, Spain, the UK, and Germany.  Celltrion was the third company to launch an ustekinumab biosimilar in Europe.

On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® across the majority of European countries.  This was quickly followed by Sandoz announcing the European launch of Pyzchiva® on 25 July 2024.

On 12 August 2025, 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 ‘606 patent relates to the use of ustekinumab (the active ingredient in Stelara®) in the treatment of ulcerative colitis.

The Swiss action is 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 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 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: 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, concluded 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 ulcerative colitis with ustekinumab.

On 5 August 2025,  CivicaScript, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026.  CivicaScript is a nonprofit company dedicated to bringing low-cost generic medicines to US patients, and will be the exclusive distributor of Fresenius Kabi’s unbranded ustekinumab-aauz.

Fresenius Kabi has already launched its branded ustekinumab biosimilar, Otulfi®, in the US in March 2025 and in Canada in May 2025.  Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024 and in Canada and the UK in January 2025.  It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US, enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025).  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.

On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:

• Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
• Celltrion’s Steqeyma®, the first biosimilar to Janssen’s Stelara® (ustekinumab) to be PBS listed; and
• Celltrion’s Omlyclo®, the first biosimilar to Genentech/Novartis’ Xolair® (omalizumab) to be PBS listed.

Each of these biosimilars is PBS listed for all reference indications.

On the same day, Arrotex Pharmaceuticals announced that it has entered into a strategic licensing agreement with Celltrion to commercialise the Celltrion ustekinumab and omalizumab biosimilars in Australia.

Celltrion’s Omlyclo® is the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

Sandoz’s Wyost® and Jubbonti® and Celltrion’s Steqeyma® were recommended for listing in Australia at the November 2024 PBAC meeting.

Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing at the March 2024 PBAC meeting, but Amgen is not proceeding with the PBS-listing and the PBAC process has ceased.  Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was recommended for PBS-listing at PBAC’s March 2025 meeting.  However, the current status of the PBS application indicates that it is inactive as Samsung Bioepis has not advised whether it intends to proceed or not within 60 days of receiving the ratified PBAC minutes.

At the November 2025 meeting, PBAC will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt® for PBS-listing for all reference indications.

On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars:

• Shanghai Henlius’ Bildyos® and Bilprevda®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), were recommended for all indications of the reference products. Henlius’ marketing authorisation application for the biosimilars (HLX14) had been accepted by the EMA in May 2024.  In June 2022, Henlius entered into a licence agreement with Organon regarding HLX14 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.  Henlius and Organon were sued by Amgen in the US in relation to their denosumab biosimilars in June 2025.
• Alteogen’s Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), received a positive CHMP opinion for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation. Alteogen submitted its MAA in July 2024.
• Biocon’s Usrenty®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), was recommended for treatment of moderate to severe plaque psoriasis in adults and children from the age of 6, active psoriatic arthritis in adults and moderately to severely active Crohn’s disease in adults. Biocon received European Commission approval for another ustekinumab biosimilar Yesintek® (Bmab 1200) in February 2025 for the same indications.  In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables commercialisation of its ustekinumab biosimilar in Europe, the United Kingdom, Canada and Japan (launch date unknown).

There are currently 6 sponsors with denosumab biosimilars approved in Europe, although none have yet been launched:  Sandoz’s Wyost® and Jubbonti® (May 2024), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce® and Biocon’s Evfraxy® and Vevzuo® (each in early July 2025), and Fresenius’ Conexxence® and Bomyntra® (late July 2025).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).

There are 7 aflibercept (2mg) biosimilars approved in Europe and not yet launched: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), and Amgen’s Pavblu® (April 2025).

There are a number of ustekinumab biosimilars now marketed in the 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 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q3/2025 edition reports that, as of June 2025, the FDA has approved 75 biosimilars, with 52 of those launched.  On average, the ASP of biosimilars remained 20-30% lower than reference biologics, with increased discounts in crowded markets, such as those for adalimumab and ustekinumab.

The biosimilars US-approved in Q3 were Bio-Thera’s Starjemza® (ustekinumab, May 2025) and Biocon’s Jobevne^™ (bevacizumab, April 2025).  Biosimilars with US launches in Q3 were Sandoz’s Jubbonti® and Wyost® (denosumab, June 2025) and Samsung Bioepis/Teva’s Epysqli® (eculizumab, April 2025).

According to the Report, biosimilars in the US have gained an average of 52% market share within 5 years post initial launch.  However, some biosimilar markets have faster uptake speeds than others; in particular, oncology, ophthalmology and pegfilgrastim biosimilars reached an average of 81% market share 5 years post launch.

In a “Biosimilar Deep Dive”, the Samsung Bioepis Report considers potential implications of the US Government’s most favoured nation (MFN) policy on the US biosimilars market.  The MFN policy aims to reduce drug costs by ensuring access to the lower prices typically paid by similar nations.  The Report concludes that, although there remains uncertainty regarding MFN implementation, the policy may result in a smaller market, reducing commercial opportunities for biosimilars to enter and compete effectively and discouraging biosimilar manufacturers from investing in new products.