Product overview
Landscape of Stelara biosimilars
The biosimilar market is evolving rapidly, with new biosimilars launching that reference Stelara (ustekinumab), a leading biologic treatment for various inflammatory diseases introduced in 2009. With the ongoing drug price negotiations set by CMS, the landscape for Stelara and biosimilars is poised for change.
The recent approvals of biosimilars referencing Stelara highlight the potential for these alternatives to enhance patient access while potentially lowering costs. The FDA has rigorously evaluated these biosimilars to ensure they meet high standards for safety, purity, and potency, providing reassurance to healthcare providers and patients alike. As the biosimilar market continues to grow, the approval of additional products signals a promising shift towards more accessible and cost-effective healthcare solutions.
Our guide to Stelara biosimilars is designed to assist in navigating this dynamic market and promote informed decision-making regarding treatment options.
Launched in the United States
Launched
| Company | Product name | Approval Date | Launch Date | Interchangeability status | Safety Information | WAC Price |
| Janssen | Stelera | Sep 25, 2009 | N/A | $27,842 |
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| Amgen/Optum/Nuvaila | Wezlana | Oct 31, 2023 | Jan 1, 2025 |
Approved | Read more | $27,564 $5,569 |
| Teva | Selarsdi | April 16, 2024 | Feb 21, 2025 |
Submitted |
Read more | $4,176 |
| Sandoz | Pyzchiva |
Jun 28, 2024 |
Feb 22, 2025 |
Submitted |
Read more |
$4,176 |
| Fresenius |
Oltufi |
Sep 27, 2024 |
Feb 22, 2025 |
Read more |
$3,620 |
|
| Biocon |
Yesintek |
Nov 29, 2024 |
Feb 22, 2025 |
Read more |
$3,000 | |
| Celltrion |
Steqeyma |
Dec 17, 2024 |
Feb 22, 2025 |
Submitted |
Read more |
$4,176 |
Pipeline
| Company | Product name | Approval Launch Date | Anticipated Launch Date | Interchangeability status | Safety Information | WAC Price |
| Accord | Imuldosa | Oct 10, 2024 | May 15, 2025 | TBD | ||
| Hikma | BAT2206 | TBD |
Source: FDA Purple Book and ClinicalTrials.gov
*WAC Pricing based on 90mg/1mL subcutaneous unit
