Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Next Previous
Trial Profile

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Alvotech

Most Recent Events

  • 05 May 2025 According to a Alvotech media release, today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). Biosimilar User Fee Act (BsUFA) goal dates for approval for the BLA is in Q4 2025.
  • 10 Jan 2024 According to a Alvotech media release, In Feb 2023, company announced that the EMA had accepted their MAA for AVT04, based on a comprehensive package of analytical and clinical data, included data from the this trial and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Pharmacokinetic similarity was demonstrated in the AVT04-GL-101 study.
  • 10 Jan 2024 According to a Alvotech media release, The European Commissions decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agencys (EMA) in November 2023 adopted a positive opinion on approving Uzpruvo with the indications Crohns disease, psoriasis and psoriatic arthritis.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top