Drugs / TEV-45779
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | persistent allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, IgE-mediated food allergy | 2026-03-30 | “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).” tevapharm.com ↗ |
| Filed | US (FDA) | — | persistent allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, IgE-mediated food allergy | 2026-03-30 | “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).” tevapharm.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04976192 | Aug 2021 → Apr 2024 | chronic urticaria | Teva Pharmaceuticals USA | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗ |
| 2026-03-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TEV-45779 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04976192 ↗ |
| Known as | Omalizumab | “TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe” NCT04976192 ↗ |
| Route | Subcutaneous | “administered sc at doses of 300 mg or 150 mg every 4 weeks” NCT04976192 ↗ |