Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved Alvotech/Cipla’s ustekinumab biosimilar, Uteknix, on 11 February 2025.
Uteknix, a biosimilar to J&J/Janssen's Stelara (ustekinumab), is available in two pre-filled syringe formulations: a 90 mg/1 mL solution for injection and a 45 mg/0.5 mL solution for injection.
The TGA has approved Uteknix for:
- Moderate to severe plaque psoriasis in adult patients eligible for phototherapy or systemic therapy.
- Active psoriatic arthritis in adults, either as monotherapy or in combination with methotrexate, for those with an inadequate response to prior non-biological DMARD therapy.
However, Uteknix is not approved for Crohn’s disease, ulcerative colitis, or patients under 18 years of age.
Commercialization and market position
Under a 2021 agreement, Cipla is commercializing Uteknix in Australia on behalf of Alvotech (developer of AVT04, the ustekinumab biosimilar).
This approval marks Uteknix as the fifth ustekinumab biosimilar approved in Australia, following:
- Samsung Bioepis’ Epyztek (October 2024)
- Celltrion’s SteQeyma (CT-P43) (September 2024)
- Amgen’s Ajemnye (May 2024)
- Amgen’s Wezlana (January 2024)
PBS (Pharmaceutical Benefits Scheme) listing status
As of now, Stelara remains the only PBS-listed ustekinumab product, but this is expected to change soon.
Amgen’s Wezlana was recommended for PBS listing at the March 2024 PBAC meeting but has not yet been added.
Celltrion’s SteQeyma received a PBS recommendation at the November 2024 PBAC meeting.
Samsung Bioepis’ Epyztek was reviewed in the March 2025 PBAC meeting.
Global approvals for ustekinumab biosimilars
Since the approvals of first ustekinumab biosimilar Wezlana [1] and Uzpruvo [2] in the US and Europe in 2023 and 2024, respectively, the European Commission (EC) and US Food and Drug Administration (FDA)each has approved six more ustekinumab biosimilars, see Table 1.
| Table 1: Ustekinumab biosimilars approved in Europe and the US
|
| Product name
|
Authorization date
|
Manufacturer/ Company name
|
Launched in market
|
| Approved by the European Commission
|
| Fymskina
|
25 Sep 2024
|
Formycon AG
|
|
| Imuldosa
|
12 Dec 2024
|
Accord Healthcare
|
|
| Otulfi
|
25 Sep 2024
|
Fresenius Kabi
|
|
| Pyzchiva
|
22 Apr 2024
|
Samsung Bioepis
|
✓
|
| SteQeyma
|
22 Aug 2024
|
Celltrion
|
✓
|
| Uzpruvo
|
5 Jan 2024
|
Alvotech/Stada
|
✓
|
| Wezenla
|
20 Jun 2024
|
Amgen
|
✓
|
| Yesintek
|
14 Feb 2025
|
Biocon
|
|
| Approved by the US FDA
|
| Imuldosa (ustekinumab-srlf)
|
10 Oct 2024
|
Accord
|
|
| Otulfi (ustekinumab-aauz)
|
27 Sep 2024
|
Formycon/Fresenius Kabi
|
|
| Pyzchiva (ustekinumab-ttwe)
|
28 Jun 2024#
|
Samsung Bioepis/ Sandoz
|
✓
|
| Selarsdi (ustekinumab-aekn)
|
16 Apr 2024
|
Alvotech, marketed by Teva
|
✓
|
| SteQeyma (ustekinumab-stba)
|
17 Dec 2024
|
Celltrion
|
|
| Wezlana (ustekinumab-auub)
|
31 Oct 2023§
|
Amgen
|
✓
|
| Yesintek (ustekinumab-kfce)
|
29 Nov 2024
|
Biocon
|
|
| §Date approved as an interchangeable biosimilar.
|
The ustekinumab market is heating up as biosimilar makers aggressively challenge the Stelara’s dominance. With eight biosimilars approved in Europe, seven in the US [3], and five in Australia, competition is intensifying—and the stakes have never been higher.
Related article
Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 30]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
2. GaBI Online - Generics and Biosimilars Initiative. EC approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 30]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-first-ustekinumab-biosimilar-uzpruvo
3. GaBI Online - Generics and Biosimilars Initiative. The ustekinumab shift: biosimilars displace Stelara’s market leadership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 30]. Available from: www.gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership
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