Drugs / AVT05
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed arthritic joint disease 1 milestone | |||||
| Filed | US (FDA) | — | arthritic joint disease | 2025-01-27 | “the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05” tevapharm.com ↗ “January 2025Alvotech and Teva announced filing acceptance of U.S. Biologics License Applications (BLAs) for AVT05” alvotech.com ↗ “The partners also announced filing acceptance of U.S. Biologics License Applications (BLAs) for AVT05” alvotech.com ↗ |
| Filed autoinflammatory disease, systemic, with vasculitis 1 milestone | |||||
| Filed | EU (EMA) | — | autoinflammatory disease, systemic, with vasculitis | 2024-11-04 | “accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.” advanzpharma.com ↗ “today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05” advanzpharma.com ↗ |
| Filed Indication not stated 2 milestones | |||||
| Filed | US (FDA) | — | — | 2026-06-04 | “today announced the resubmission to the U.S. Food and Drug Administration (FDA) of Biologics License Applications (BLAs) for AVT05” alvotech.com ↗ |
| Rejected (CRL) | US (FDA) | — | — | 2025-11-02 | “the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05” alvotech.com ↗ “as a result of the CRL received for AVT05 (PFS/AI and vial presentations)” alvotech.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05632211 | Dec 2022 → Oct 2023 | — | Alvotech Swiss AG | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05842213 | Mar 2023 → Mar 2024 | rheumatoid arthritis | Alvotech Swiss AG | Completed | Met primary |
News releases announcing trial results or a regulatory action · 15
| 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 ↗ |
| 2025-11-20 | Alvotech Swiss AG | Regulatory Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“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 Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab). |
| 2025-11-20 | Advanz Pharma | Regulatory Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz® a Biosimilar to Simponi® (golimumab) advanzpharma.com ↗
today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab). |
| 2025-11-06 | Advanz Pharma | Regulatory Alvotech and Advanz Pharma Receive Marketing Authorisations for Gobivaz®, a Biosimilar to Simponi® (golimumab), from the MHRA advanzpharma.com ↗ |
| 2025-11-02 | Alvotech Swiss AG | Regulatory Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05 alvotech.com ↗
The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. |
| 2025-09-22 | Alvotech Swiss AG | Regulatory European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner alvotech.com ↗
The positive CHMP opinion for Gobivaz® is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe. |
| 2025-09-22 | Advanz Pharma | Regulatory European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner advanzpharma.com ↗
today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. |
| 2025-09-19 | Alvotech Swiss AG | Regulatory Alvotech Announces Marketing Approval in Japan of Three New Biosimilars alvotech.com ↗
AVT05, approved in Japan as GOLIMUMAB BS 50 mg PFS for subcutaneous injection, is a biosimilar to Simponi® (golimumab). |
| 2025-01-27 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab) alvotech.com ↗
These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. |
| 2025-01-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab) tevapharm.com ↗
These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. |
| 2024-11-13 | Alvotech Swiss AG | Regulatory Alvotech Reports Financial Results for the First Nine Months of 2024 alvotech.com ↗
Alvotech announced that the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab) and an MAA for AVT05, a proposed biosimilar to Simponi® (golimumab). |
| 2024-11-04 | Alvotech Swiss AG | Regulatory European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab) alvotech.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 (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. |
| 2024-11-04 | Advanz Pharma | Regulatory European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab) 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 (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. |
| 2024-04-24 | Alvotech Swiss AG | Results Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi® (golimumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab). |
| 2023-11-29 | Alvotech Swiss AG | Results Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria® alvotech.com ↗
The study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects, met its primary endpoints. |
All press releases naming this drug 18 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT05 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05632211 ↗ |
| Modality | Monoclonal antibody | “AVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody” PMID 41212475 ↗ Nov 2025 |
| Route | Subcutaneous | “Participants received a single 50 mg/0.5 mL subcutaneous injection on Day 1” PMID 41212475 ↗ Nov 2025 |