The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the US, the competition is fierce, and the stakes are high.
Global Stelara sales dropped 14.7% year-over-year to roughly US$2.3 billion in 2024’s fourth quarter. For the full 12-month earnings period, Stelara sales slipped around 4.6% to US$10.4 billion. This decline marks the beginning of a seismic shift in the market, driven by biosimilars from players like Alvotech, Amgen, Biocon, and Samsung Bioepis.
The First Movers and the Race to Market
Amgen’s Wezlana made history as the first ustekinumab biosimilar with interchangeable designation approved in the US on 23 October 2023 [1], setting the stage for a wave of competitors. In Europe, Alvotech and STADA’s Uzpruvo is the first ustekinumab biosimilar approved on 5 January 2024 [3]. These first movers have a critical advantage: early market penetration and the opportunity to establish trust among healthcare providers and patients.
Since the approvals of Wezlana and Uzpruvo 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. Additionally, Biocon’s Yesintek has received a positive opinion from CHMP and is pending for EC approval, bringing the total number of ustekinumab biosimilars competing in Europe and the US to 15. Table 1 lists these biosimilars, their authorization dates and launch status in Europe and the US.
| 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
|
CHMP positive opinion 12 Dec 2024
|
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
|
|
A new era for autoimmune treatment
Analysts predict that Stelara’s market share will continue to erode as biosimilars gain approval and adoption. The biosimilar wave is not just about price competition—it’s about reshaping the treatment landscape for millions of patients with psoriasis, Crohn’s disease, and ulcerative colitis. Biosimilars make these life-changing therapies more accessible and affordable.
Upcoming ustekinumab biosimilars
The pipeline for ustekinumab biosimilars remains robust. Formycon’s FYB202 is pending for FDA approval, while Bio-Thera’s BAT2206 and BioFactura/CuraTeQ’s BFI-751 are in clinical trials. If approved, these candidates will bring the total number of ustekinumab biosimilars to 18, mirroring the competitive landscape of adalimumab biosimilars. This influx is expected to further intensify competition, driving down prices and improving patient access.
Currently, the originator biological Humira is the only product with 18 adalimumab biosimilars approved in Europe (8) and the US (10). Meanwhile, Stelara has 15 approved ustekinumab biosimilars, making ustekinumab the second most competitive biosimilar market, following adalimumab.
Related articles
Disruptor partnerships grow adalimumab biosimilar market share
Uzpruvo/AVT04 biosimilar in profile
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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 Mar 12]. 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 Mar 12]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-first-ustekinumab-biosimilar-uzpruvo
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