On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease.  Stelara® is now the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adults and children with moderately to severely active Crohn’s disease.

The approval is based on data from the Phase 3 UNITI-Jr clinical study, a multi-centre interventional study to evaluate the efficacy, safety, and pharmacokinetics of Stelara® for the treatment of paediatric Crohn’s disease over 52 weeks.

Stelara® is facing significant competition from biosimilars globally, including in the US, following 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), Samsung Bioepis’/Sandoz’s Pyzchiva® (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® (August 2025) and Bio-Thera/Hikma’s Starjemza™ (November 2025).

At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:

• 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;
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS;
• Amgen’s Wezlana® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion.

Amgen’s high concentration adalimumab biosimilar, Amgevita®, was TGA-approved in September 2025, while Celltrion’s high concentration adalimumab Yuflyma® was TGA-approved in September 2024, June 2023 and March 2022 as 20mg/0.2ml PFS, 80mg/0.8ml and 40mg/0.4ml, respectively.  Yuflyma® was first PBS-listed in March 2023 (40mg/0.4ml).  There are a number of other high concentration biosimilars to AbbVie’s Humira® approved in Australia, including Samsung Bioepis’ Hadlima® (approved February 2023, PBS-listed by Organon October 2024) and Sandoz’s Hyrimoz® (approved May 2024 and PBS-listed January 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was previously PBS-listed on 1 August 2025 (in 75 mg/0.5ml and 150 mg/1ml PFS) and was launched in Australia in September 2025.  The March 2026 PBAC recommendation relates to the pre-filled pen presentation, which was TGA approved in August 2025.

Amgen’s Wezlana® (ustekinumab), biosimilar to Janssen’s Stelara®, was first recommended for PBS listing at PBAC’s April 2024 meeting.  However, Amgen did not proceed with the listing at that time and requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting.  PBAC has extended its March 2024 recommendation for a further 12 months, supporting the PBS listing of Wezlana®.

Sandoz’s Ardelya® (ustekinumab) has also been recommended for PBS listing but is yet to receive 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 has not yet progressed to PBS listing, pending lodgement of required documentation.

On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q2/2026 edition reports that, as of March 2026, the FDA has approved 92 biosimilars across 20 unique biosimilar molecules, 67 of which have been launched in the US.  This is an additional 2 biosimilars approved and 3 launched since Q1/2026.  The biosimilars FDA approved in Q1/2026 were Accord Biopharma’s Filkri™ (filgrastim) (referencing Amgen’s Neupogen®) and Teva Pharmaceutical’s Ponlimsi™ (denosumab) (referencing Amgen’s Prolia®)  The Q1/2026 launches were Samsung Bioepis’ Ospomyv® (denosumab) (referencing Amgen’s Prolia®) and Gedeon Richter/Hikma’s Enoby® and Xtrenbo® (denosumab) (referencing Amgen’s Prolia® and Xgeva®, respectively).

Samsung Bioepis reports as “key highlights” increases in US market share of adalimumab biosimilars (to 60% as of February 2026), and ustekinumab biosimilars (an increase of 8% to 27% as of Q4/2025).  The increase in adalimumab biosimilar adoption is said to reflect the inclusion of Quallent private label sales in market share calculations beginning in 2026.

The Biosimilar Market Report summarises the FDA’s October 2025 and March 2026 draft guidance regarding streamlining biosimilar development, including by indicating that Clinical Efficacy Studies (CES) are no longer expected by default and clarifying that clinical data generated using a non-US-licensed comparator product may be used to support a US biosimilar application, provided sufficient scientific justification is established.  The Report concludes that reduced reliance on CES and increased flexibility in comparator sourcing “may lower development cost and complexity” and “may enable development across a broad set of reference products particularly in later-wave or smaller markets”.  However, the Report refers to market research suggesting that reduced reliance on CES is unlikely to materially impact coverage or formulary positioning, as FDA approval is viewed as the threshold for equivalence.

On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan.  The newly approved formulation adds to Celltrion’s subcutaneous (SC) formulation of Steqeyma®, which was launched in Japan in July 2025 following its March 2025 approval.

Both formulations of Steqeyma® are approved in Japan for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s Disease.

Celltrion’s SC formulation of Steqeyma® was the third ustekinumab biosimilar launched in Japan, following Alvotech/Fuji Pharma’s launch of AVT04 in May 2024 and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, launched in May 2025.  Samsung Bioepis received Japanese approval for its ustekinumab biosimilar, Nipro™, in December 2025.

Steqeyma® has been launched around the world including in the US (March 2025), Europe (November 2024), and Australia (listed on the PBS from 1 August 2025).

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).