Drugs / AVT06
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2025-02-18 | “have been accepted for review by the FDA: AVT05, a proposed biosimilar for Simponi® (golimumab) and Simponi Aria® (golimumab), and AVT06” tevapharm.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06” tevapharm.com ↗ |
| Filed | EU (EMA) | — | — | 2024-08-15 | “the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept).” advanzpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05155293 | Jun 2022 → Nov 2023 | wet macular degeneration | Alvotech Swiss AG | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-04 | Alvotech Swiss AG | Regulatory Alvotech announces resubmission of U.S. Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and AVT06, a proposed biosimilar to Eylea® alvotech.com ↗ |
| 2025-09-19 | Alvotech Swiss AG | Regulatory Alvotech Announces Marketing Approval in Japan of Three New Biosimilars alvotech.com ↗
AVT06, approved in Japan as AFLIBERCEPT BS 40 mg/mL solution in PFS for IVT injection and 40 mg/mL vial kit for IVT injection, is a biosimilar to Eylea® (aflibercept). |
| 2025-08-21 | Advanz Pharma | Regulatory Advanz Pharma and Alvotech receive European approval for Mynzepli®, Biosimilar to Eylea® advanzpharma.com ↗
The European Commission’s decision to issue a marketing authorization came after the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on approving AVT06, as Mynzepli® (aflibercept). |
| 2025-06-23 | Alvotech Swiss AG | Regulatory European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept) alvotech.com ↗
CHMP’s positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers. |
| 2025-06-23 | Advanz Pharma | Regulatory European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept) advanzpharma.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). |
| 2025-02-18 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) alvotech.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06 |
| 2025-02-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) tevapharm.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06 |
| 2024-08-15 | Alvotech Swiss AG | Regulatory European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) alvotech.com ↗
today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). |
| 2024-08-15 | Advanz Pharma | Regulatory European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) advanzpharma.com ↗
the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept) |
| 2024-01-03 | Alvotech Swiss AG | Results Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept) alvotech.com ↗
The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea. |
All press releases naming this drug 16 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT06 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05155293 ↗ |
| Route | Intravitreal | “Patients will receive IVT injections of AVT06” NCT05155293 ↗ |