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.

On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab).  This includes the addition of Yeskintek® to the National Preferred Formulary (NPF) from 21 March 2025, Cigna’s commercial formulary from 21 March 2025, various United Healthcare formularies from 21 March 2025 and managed Medicaid from 1 March 2025.  Yesintek® is also due to be added to Medicare from 1 June 2025, CVS Health from 1 July 2025 and Optum Rx from 1 July 2025.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

In March 2025 Celltrion announced the addition of its ustekinumab biosimilar, Steqeyma® to the US Costco Member Prescription Program.  According to Samsung Bioepis’ Q1/2025 US Biosimilar Market Report, ustekinumab biosimilar entrants to the US market in 2025 have provided steep WAC discounts of over 80%.

On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

According to an Alvotech/Teva announcement in February 2025, the FDA had granted Selarsdi® a provisional determination of interchangeability to commence after the expiry of exclusivity for Amgen’s Wezlana® (the first ustekinumab biosimilar to be approved as interchangeable in the US) on 30 April 2025.  Wezlana® and Selarsdi® are the only ustekinumab biosimilars currently approved by the FDA as interchangeable with Stelara®.

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.  Four other ustekinumab biosimilars have also been launched in the US to date: 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).

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 1 May 2025, 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.  Neither the Court’s ruling on the preliminary injunction, nor the appeal filing, are publicly accessible as at 1 May 2025.

Subject to the outcome of the appeal, Samsung Bioepis is now clear to sell private label brands in the US, in addition to Pyzchiva® which Samsung Bioepis has been selling since February 2025.

J&J/Janssen commenced the US action on 24 February 2025, alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claimed that Samsung Bioepis had entered into an unauthorised sublicence with a private label provider, described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM).  According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of biosimilar ustekinumab.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

On 24 April 2025, Samsung Bioepis published its ninth quarterly 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 Q2/2025 edition reports that, as of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules, with 48 of those having launched in the US market.  Of note, in Q1/2025, six new ustekinumab biosimilars were 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).  According to Samsung Bioepis’ Report, ustekinumab biosimilar entrants provided steep WAC discounts of over 80%.  In comparison, Amgen’s Pavblu®, the only aflibercept biosimilar available in the US at the time of the Report, launched with WAC 12% lower than that of Regeneron’s Eylea®.

The Report also outlines reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s guidance on biosimilar interchangeability.

On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program.  Steqeyma® will be available from US Costco Specialty Pharmacies from 1 April 2025 for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma® prescription or who have been denied coverage by their insurers.  According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® was launched in the US in March 2025 for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, paediatric plaque psoriasis and paediatric psoriatic arthritis.

In August 2024, Celltrion also announced the addition of adalimumab-aaty, biosimilar to AbbVie’s Humira®, to the Costco Member Prescription Program.

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to Janssen’s Stelara®.

Under the agreement, Lumicera’s discounted net acquisition cost is estimated to generate USD$120 million in annualised savings.  These savings will be accessed immediately through Lumicera’s pass-through, acquisition cost-plus model, not delayed through a rebated model.  Plan sponsors will save between USD$112,000 and $336,000 per patient per year compared to the annual per-patient cost of the reference product.

Earlier this year, on 21 February 2025, Alvotech and Teva announced the US launch of ustekinumab biosimilar, Selarsdi® (AVT04, ustekinumab-aekn for injection).  This followed Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025.

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an agreement 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 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and paediatric psoriatic arthritis.

According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® received US FDA approval in December 2024 and was launched across 5 major EU countries in January 2025.

The US launch of Steqeyma® follows the US launches of Formycon/Fresenius Kabi’s Otulfi®/FYB202 (ustekinumab-aauz) in early March 2025, Sandoz/Samsung Bioepis’ Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce/Bmab 1200) on 24 February 2025, Alvotech/Teva’s Selarsdi® (ustekinumab-aekn) on 21 February 2025 and Amgen’s Wezlana® (ustekinumab-auub) in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).