TEV-45779 (omalizumab biosimilar) / Teva - LARVOL DELTA

…Teva’s applications for a proposed biosimilar candidate to Xolair (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency (EMA). (Teva Press Release) - "Both applications include all indications approved for the reference product, Xolair– moderate-to-severe (U.S.)/severe (EU) persistent allergic asthma (ages 6+), chronic rhinosinusitis with nasal polyps (adults 18+), chronic spontaneous urticaria (ages 12+) and, in the U.S., IgE-mediated food allergies (ages 1+). These regulatory applications are supported by a comprehensive data package that includes analytical and clinical data on efficacy, safety and immunogenicity similar to Xolair (omalizumab)."

EMA filing • FDA filing • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Food Hypersensitivity • Immunology

Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=608 | Completed | Sponsor: Teva Pharmaceuticals USA | Trial primary completion date: Sep 2023 ➔ Apr 2024

Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=608 | Completed | Sponsor: Teva Pharmaceuticals USA | Active, not recruiting ➔ Completed

Trial completion • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Teva Pharmaceuticals USA | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: Teva Pharmaceuticals USA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Urticaria