On 16 September 2026, Fuji Pharma announced that it has obtained marketing approval in Japan for Golimumab BS 50 mg autoinjector for subcutaneous injection (AVT05), biosimilar to Janssen’s Simponi® (golimumab), and Ustekinumab BS 130 mg intravenous infusion (AVT04), biosimilar to Janssen’s Stelara® (ustekinumab).

Fuji Pharma is Alvotech’s commercialisation partner in Japan for both products.  Alvotech and Fuji Pharma first announced they had entered into a commercialisation agreement for Japan in 2018, with the agreement expanded in February 2022 and January 2023.

Biosimilar Golimumab

Fuji already markets a pre-filled syringe presentation of the golimumab biosimilar (AVT05) in Japan, which was approved in September 2025 as Gobivaz®, the first biosimilar golimumab approved worldwide.  Gobivaz® was launched in Japan in May 2026 and remains the only biosimilar golimumab on the Japanese market.  Under a settlement agreement entered with Janssen in November 2025, the autoinjector form of AVT05 will be eligible for National Health Insurance (NHI) drug price listing and commercial launch in Japan from May 2027.

Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.  In June 2026, Alvotech resubmitted its BLA for AVT05 to the FDA after receiving a complete response letter, and was then sued for patent infringement in BPCIA litigation commenced by Janssen on 19 June 2026.

Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.

Biosimilar Ustekinumab

Alvotech/Fuji Pharma’s biosimilar ustekinumab was first approved in Japan in September 2023 and launched in May 2024 in 45 mg and 90 mg subcutaneous formulations.  The newly approved ustekinumab biosimilar for intravenous (IV) administration expands Fuji’s portfolio, enabling it to provide treatment options covering both induction and maintenance therapy for moderately to severely active Crohn’s disease.

Fuji is aiming for NHI drug price listing and launch of its IV ustekinumab biosimilar in November 2026.

Fuji Pharma’s IV ustekinumab approval follows Samsung Bioepis/Nipro’s Ustekinumab BS Intravenous Infusion, which was approved in Japan earlier in September 2026, and Celltrion’s IV formulation of Steqeyma® (ustekinumab), which was approved in Japan in April 2026 and launched in August 2026.  Subcutaneous ustekinumab biosimilars already launched in Japan include those of Biocon/Yoshindo (May 2025), Celltrion (July 2025), and Samsung Bioepis (May 2026).

On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was approved in Japan as induction therapy for moderate to severely active Crohn’s disease, where other treatments are ineffective.

The approval of the IV formulation comes 9 months after Samsung Bioepis’ subcutaneous ustekinumab (45 mg syringe) was approved in Japan (December 2025).  It was subsequently launched in May 2026.  Samsung Bioepis’ biosimilar ustekinumab is being commercialised in Japan by Nipro under the terms of a June 2025 agreement.

Samsung Bioepis’ IV formulation of ustekinumab closely follows Celltrion’s IV formulation of Steqeyma® (ustekinumab), which was approved in Japan in April 2026 and launched in August 2026. Steqeyma® (IV and SC) is indicated for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s disease.

Other ustekinumab biosimilars launched in Japan include Alvotech/Fuji Pharma’s AVT04 (May 2024) and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, (May 2025).

On 28 August 2026, the FDA announced that it approved Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC) in children aged 2 years and older. The new paediatric UC indication follows the US approval of Stelara® for paediatric Crohn’s disease in April 2026.

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 (Pyzchiva® launched 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).

On 21 August 2026, Celltrion announced that it has launched Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in an intravenous (IV) formulation in Japan.

Celltrion’s IV formulation of Steqeyma® was approved in Japan in April 2026, with the subcutaneous formulation launching in July 2025 following its March 2025 approval.  Both formulations of Steqeyma® are approved in Japan for psoriasis and psoriatic arthritis, and the IV formulation is additionally approved for Crohn’s Disease.

Celltrion is one of a number of biosimilar competitors that have launched ustekinumab products in Japan, including, Alvotech/Fuji Pharma (May 2024), Biocon/Yoshindo (May 2025) and Samsung Bioepis (May 2026).

On 21 August 2026, the outcomes of the July 2026 meeting of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) were published, with the following biosimilars recommended for PBS listing:

• Biocon/Generic Health’s Yesintek® (ustekinumab), biosimilar to Janssen’s Stelara®, for first time PBS listing (5 mg/0.5 mL injection, 45 mg/0.5 mL and 90 mg/1 mL pre-filled syringe (PFS) and 130 mg/26 mL solution for IV infusion). Yesintek® was approved by the TGA in each of these presentations in April 2026.
• Celltrion’s Steqeyma® (ustekinumab) for 3 new formulations (45 mg/0.5 mL vial, and 45 mg/0.5 mL and 90 mg/1 mL pre-filled pen (PFP)). Steqeyma® was the first ustekinumab biosimilar to be PBS listed on 1 August 2025 (45 mg/0.5 mL and 90 mg/1 mL PFS and 130 mg/26 mL solution for IV infusion).
• Celltrion’s Eydenzelt® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2 mg, for four additional indications: subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD), diabetic macular oedema (DMO), branch retinal vein occlusion (BRVO) with macular oedema (MO) and central retinal vein occlusion (CRVO) with MO. Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV).  Although recommended for PBS listing in November 2025 for the same indication, it has not yet completed the government processes required for PBS listing.

In addition to Steqeyma®, the only other ustekinumab biosimilar currently listed on the PBS is Amgen’s Wezlana®.  Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time.  Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.

Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting.  Samsung Bioepis lodged documentation required for PBS listing on 10 July 2026, with the next step in the process (agreement on listing arrangements) having commenced on 14 July 2026.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

The only Eylea® (aflibercept) biosimilar that is PBS listed in Australia is Sandoz’s Afqlir®, which was listed in February 2026 in vial and pre-filled syringe presentations for all reference indications.

On 18 August 2026, Biocon announced that it has received supplemental FDA approval for Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), in a single-dose prefilled autoinjector format (45 mg/0.5 ml and 90 mg/ml).

Biocon first launched Yesintek® in the US in February 2025 (in PFS and vial presentations), following Yesintek®’s original FDA approval in November 2024.  The timing of Biocon’s US launch was governed by a US settlement and licence agreement with Janssen (entered in February 2024), including to resolve an Inter Partes Review Petition.

There are currently seven other FDA-approved ustekinumab biosimilars in the US market: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (FDA-approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (FDA-approved April 2024; launched February 2025; interchangeability status May 2025), Samsung Bioepis’ Pyzchiva® (FDA-approved July 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (FDA-approved September 2024; launched March 2025), Celltrion’s Steqeyma® (FDA-approved December 2024; launched March 2025) and Hikma’s Starjemza™ (FDA-approved May 2025; launched November 2025).

On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®), biosimilar to Janssen’s Stelara®, in an autoinjector pen format (45 mg/0.05mL and 90 mg/mL).

Yesintek® was first approved in Canada in October 2025 in the following formulations: solution for subcutaneous injection, 45 mg/0.5mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe); and solution for intravenous infusion, 130 mg/26mL (5 mg/mL).  The product was launched in Canada in the same month.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen for Canada, Japan, Europe and the UK.  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.

Other ustekinumab biosimilars approved and launched in Canada to date, include 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, with an autoinjector form approved in March 2026), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Samsung Bioepis’ Pyzchiva™ (approved August 2024, 2026 launch planned) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

On 22 July 2026, Medtas announced that it has launched a new in-pharmacy program (myMedtas-Care), following the 1 July 2026 listing of Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab), on the Australian Pharmaceutical Benefits Scheme (PBS).  The in-pharmacy program allows credentialled community pharmacists to administer subcutaneous Wezlana® injections for patients.

Wezlana® is manufactured by Amgen and is the first ustekinumab biosimilar in Australia to be PBS-listed across all product formats of the originator.  It is currently listed in 130 mg and 45 mg vial, and 45 mg and 90 mg pre-filled syringe, presentations.

The only other ustekinumab biosimilar currently PBS-listed in Australia is Celltrion’s Steqeyma® (1 August 2025).  Steqeyma® is not PBS listed in the 45 mg vial presentation.

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.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

On 16 July 2026, Organon and Samsung Bioepis announced the expansion of their development and commercialisation agreement for Australia, to include a new biosimilar.  While the biosimilar has not been named by Organon or Samsung Bioepis, Pharma in Focus has suggested that it may be Epyztek®, biosimilar to J&J’s Stelara® (ustekinumab).

Under the terms of the expanded agreement, Organon will obtain the exclusive Australian commercialisation rights to the biosimilar, while Samsung Bioepis will maintain full development, manufacturing and regulatory responsibilities.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting.  The drug has not yet been PBS-listed pending lodgement of required documentation.

In October 2025, Samsung Bioepis successfully opposed Janssen’s Australian patent application (AU2019346134) relating to a method of treating ulcerative colitis (UC) with Stelara® (ustekinumab).

This followed a decision of the Federal Court of Australia in June 2025, ordering 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), which related to methods of treating UC with ustekinumab.

Organon is currently sponsoring three of Samsung Bioepis’ biosimilars in Australia under the existing agreement: Brenzys® (etanercept), which was TGA-approved July 2016 and PBS-listed July April 2017; Renflexis® (infliximab), TGA-approved November 2016 and PBS-listed August 2017; and Hadlima® (adalimumab), TGA-approved in January 2018, launched March 2021 and PBS-listed in April 2021.

In June 2026, the companies announced the expansion of their Canadian collaboration, first established in 2013, from five to six biosimilars to include Pyzchiva®, biosimilar to J&J’s Stelara (ustekinumab).

On 13 July 2026, Seoul Economic Daily reported that Samsung Bioepis has secured US formulary listings for Pyzchiva®/SB17, with two major pharmacy benefit managers (PBMs).

Pyzchiva® was listed as a preferred drug by CVS Caremark from 1 July 2026, following the inclusion of Pyzchiva® on the Express Scripts (ESI) formulary earlier this year.  According to the announcement, CVS Caremark and ESI cover 57% of the US PBM market, broadening patient access.

Samsung Bioepis also supplies private label versions of Pyzchiva® through agreements with distribution subsidiaries of these PBMs, including Quallent (an ESI subsidiary) and Cordavis (a CVS Caremark subsidiary).  The private label versions of Pyzchiva® are supplied under the proprietary brands of the PBM subsidiaries.

The reference drug, J&J’s Stelara® (ustekinumab) is excluded from major formularies in the US.  In May 2026, it was reported that from 1 July 2026, CVS Health would preference lower-cost, interchangeable biosimilars over Stelara® in its most common drug lists.  CVS Health’s pharmacy benefit management unit, Caremark, will transition to biosimilar versions of Stelara®, such as Sandoz/Samsung Bioepis’ Pyzchiva® and Biocon Biologics’ Yesintek™.

Pyzchiva® was developed by Samsung Bioepis and is commercialised by Sandoz in the US pursuant to a deal entered into in September 2023.  The FDA approved Pyzchiva® in July 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

There are currently seven other FDA-approved ustekinumab biosimilars in the US market: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (FDA-approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (FDA-approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (FDA-approved in December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (FDA-approved September 2024; launched March 2025), Celltrion’s Steqeyma® (FDA-approved December 2024; launched March 2025) and Hikma’s Starjemza™ (FDA-approved May 2025; launched November 2025).