Date: 2016-06-16
Type of
information: Clinical trial autorization
phase: 3
Announcement: clinical trial authorization
Company: Oncobiologics (USA - NJ)
Product: ONS-3010 (biosimilar version of Humira® (adalimumab))
Action
mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor. ONS-3010 is a biosimilar version of Humira® (adalimumab). Humira® is used to treat many conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.
Disease: moderate to severe plaque psoriasis
Therapeutic
area: Autoimmune diseases - Dermatological diseases
Country: Germany, Spain, UK
Trial
details:
Latest
news:
- • On June 16, 2016, Oncobiologics announced that its Phase 3 clinical plan for ONS-3010 (Humira® biosimilar) has received the first of its European Union (EU) clinical trial authorization (CTA) approvals, including in the United Kingdom, Germany and Spain, for the biosimilarity study portion of the Phase 3 clinical program.
The global Phase 3 clinical program for ONS-3010 is expected to include recruitment and treatment of patients in approximately 20 countries, including the United States and various member states of the EU. The program study design is based on input from multiple Health Authorities including the FDA and European Medicines Agency (EMA), and will include testing intended to enable interchangeability for Humira® in the United States. The Phase 3 program will be conducted in patients with moderate to severe plaque psoriasis and is anticipated to begin dosing patients later in 2016.
Is
general: Yes
