Date: 2013-12-18
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the study
Company: Sandoz (Switzerland)
Product: biosimilar version of Humira® (adalimumab)
Action mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor
Disease: psoriasis
Therapeutic area: Allergic diseases - Inflammatory diseases - Dermatological diseases
Country: Europe, USA and Asia including Japan
Trial details:
Latest
news: * On December 18, 2013, Sandoz has announced it has initiated a Phase III clinical trial with its biosimilar version of adalimumab (AbbVie’s Humira®). This is Sandoz’s eighth Phase III trial initiation across six compounds. This is also Sandoz’ sixth biosimilar molecule to enter Phase III testing. Trial will support registration in the U.S. and European Union.
The aim of the study is to demonstrate equivalent efficacy, similarity, and immunogenicity of the Sandoz product versus Humira® in patients with moderate to severe plaque-type psoriasis. Sandoz is working closely with physicians and patients on this global trial, which spans 12 countries across Europe, the United States and Asia including Japan.
