On 6 January 2026, Fresenius Kabi announced that it has introduced a new presentation of Otulfi®, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab), in a 45 mg/0.5 mL single-dose vial for subcutaneous injection.

Following the introduction of this new presentation, Fresenius Kabi now offers all dosage forms and strengths of Stelara®, with Fresenius Kabi’s Otulfi® also having received interchangeability designation from the FDA in May 2025.

Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling the US launch of Otulfi® in March 2025.

There are a number of other 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), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial formularies, including National Preferred Formulary, starting 5 September 2025.  Express Scripts is one of the United States’ largest pharmacy benefit managers.  Accord’s announcement follows the commercial launch of Imuldosa® in the US in August 2025.

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

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 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 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 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.

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 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 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in all presentations of the reference product.

FYB202/Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202/Otulfi® “no later than 15 April 2025”.  FYB202/Otulfi® was the fourth ustekinumab biosimilar to be launched in the US in early March 2025.

Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US on October 2023, followed by Alvotech/Teva’s Selarsdi® in early May 2025.