Trial Profile

A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara in Patients with Moderate-to-Severe Plaque Psoriasis

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 26 May 2025

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At a glance

19 May 2025 According to a Formycon media release,company announced that the U.S. Food and Drug Administration (FDA) designated Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara (ustekinumab).
03 Mar 2025 According to a Formycon media release, drug received FDA approval in September 2024 and FDA for both subcutaneous and intravenous formulations, to treat the same conditions as the reference product Stelara (ustekinumab).
20 Feb 2025 According to a Formycon media release, data from this study will be presented at the European Crohns and Colitis Organisation (ECCO) Congress

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