On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Germany.  German launch of Fymskina® is planned for Q3 2025.

Under the agreement, which follows the European Commission’s approval of Fymskina®/FYB202 in September 2024, Formycon is responsible for manufacture and supply, and Ratiopharm is responsible for commercialisation.

Formycon entered into a global commercialisation partnership for FYB202 with Fresenius Kabi in February 2023, in which Formycon retained secondary commercialisation rights for Germany, parts of Latin America, and the MENA region.  Pursuant to the global commercialisation agreement, Formycon and Fresenius Kabi launched FYB202 (marketed as Otulfi®) in Canada in May 2025 and in the US in March 2025 (securing US interchangeability for FYB202 in May 2025).  Formycon also separately entered into a licence/supply agreement with MS Pharma for countries in the MENA region in December 2024.

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruko® (natalizumab, biosimilar to Biogen’s Tysabri®).

Celltrion’s Steqeyma® is set to become the first biosimilar to Janssen’s Stelara® (ustekinumab) to be listed on the PBS.  The product has reached the final “government processes” stage, indicating that PBS-listing is imminent.  Steqeyma® was recommended in December 2024 following its consideration at PBAC’s November 2024 meeting.  Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for listing at the March 2024 PBAC meeting, however Amgen is not proceeding with the PBS-listing and the PBAC process has ceased.  Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but remains in the earlier stages of application.

Viatris’ Nepexto® may soon become the second biosimilar to Pfizer’s Enbrel® (etanercept) subsidised under the PBS, also reaching the final “government processes” stage.  Samsung Bioepis/Arrow Pharma’s Brenzys® was the first PBS-listed etanercept biosimilar in April 2017.

Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is also approaching PBS listing, following its recommendation in PBAC’s March 2025 meeting and approval as the first and only natalizumab biosimilar in Australia (April 2025).  Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab.

STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), were each recommended (as 40 mg/ml solution for injection in pre-filled syringes and vials) for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), 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) and Amgen’s Pavblu® (April 2025).  Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.

Bio-Thera Solution’s Usympro® (BAT2206), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) also received a positive CHMP opinion, for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.  Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for Usympro®/BAT2206 in October 2024, under which Bio-Thera is responsible for the development and manufacturing of the product while Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it is to be commercialised by Hikma Pharmaceuticals under the name Starjemza®.

A sixth biosimilar recommended by the CHMP at its June meeting was Biocon’s Vivlipeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.  The recommendation comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The new presentation is approved for the treatment of paediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis.  The FDA has also granted Steqeyma® full interchangeability with Stelara® across all its indications.

Steqeyma® was first approved by the FDA in December 2024 in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and paediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis.  Celltrion launched Steqeyma® in the US in these presentations in March 2025.

Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US in October 2023, followed by Alvotech/Teva’s Selarsdi® and Formycon/Fresenius’ FYB202/Otulfi®, both in May 2025.

There are a number of ustekinumab biosimilars now launched in the US including Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), and Formycon/Fresenius Kabi’s Otulfi® (Mar 2025).

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 ulcerative colitis with ustekinumab.  The Court is yet to issue any reasons for judgment in these proceedings.

This is a second victory for Samsung Bioepis in Australia with the earlier January 2024 Federal Court of Australia patent proceeding concluding with Janssen surrendering the two innovation patents in suit.  These innovation patents again related to a method of treating ulcerative colitis with ustekinumab.

Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was approved in Australia in October 2024.  Other ustekinumab biosimilars approved in Australia are Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).

Janssen’s Stelara® remains the only PBS-listed ustekinumab product at this stage.  Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but the company has advised that it is not proceeding in the PBS listing process at this time.  Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting and Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting.

On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Janssen’s Stelara® (ustekinumab).

Under the terms of the agreement, Samsung Bioepis is responsible for the development, manufacture and supply of the biosimilars, with NIPRO responsible for their commercialisation in Japan.

This follows Biocon Biologic’s announcement on 21 May 2025, that its commercial partner, Yoshindo, launched Ustekinumab BS Subcutaneous Injection in Japan for the treatment of psoriasis vulgaris and psoriatic arthritis.  In September 2023, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, had received marketing approval for AVT04 (ustekinumab) from the Japanese Ministry of Health, Labor and Welfare.

On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC).  Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, which was approved by the EC in August 2024 and launched in the EU in November 2024.

Qoyvolma® received a positive opinion from the EMA’s CHMP in March 2025.  It has been approved with an additional indication to that of Steqeyma®, with moderately to severely active ulcerative colitis in adults included in its list of indications, together with adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.

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.  Approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The biosimilar is available in both IV and subcutaneous injection presentations to treat adults with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

FYB202/Otulfi® was developed by Formycon and was approved in Canada and the UK in January 2025 and in the US and Europe in September 2024.  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 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).

The approval of Starjemza® follows six ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).

Bio-Thera and Hikma signed an exclusive commercialisation and licence agreement in relation to BAT2206/Starjemza® in August 2021.  Under the agreement, Hikma has exclusive commercialisation rights in the US while Bio-Thera remains responsible for the development and manufacturing of the product.

Bio-Thera also has commercialisation and licence agreements for BAT2206/Starjemza® with Gedeon Richter for the EU, UK, Switzerland and selected other countries (entered October 2024), Dr Reddy’s for certain Southeast Asian countries including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam (entered March 2025), World Medicine for Turkey (entered January 2025), and Tabuk Pharmaceuticals for Saudi Arabia (entered December 2024).

On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  Yesintek® is indicated for treatment of adults and children from 6 years with moderate to severe plaque psoriasis and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.

The European Commission granted marketing authorisation for Yesintek™ in February 2025.  In the same month, Biocon launched Yesintek® in the US, following its US approval in early December 2024.

In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan (launch date unknown).

There are a number of ustekinumab biosimilars already approved in the UK, including Dong A-ST/Intas’ Imuldosa® (launched April 2025), Formycon/Fresenius’ Otulfi®/FYB202 (approved January 2025), Celltrion’s Steqeyma® (approved September 2024), Samsung Bioepis’ Pyzchiva® (approved May 2024), STADA’s Uzpruvo® (approved March 2024) and Amgen’s Wezenla™ (approved January 2024).