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
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

 

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