AVT03
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | osteoporosis, cancer-related bone disease | 2025-03-18 | “Reddy’s Laboratories announced filing acceptance of U.S. Biologics License Application for AVT03, a proposed biosimilar to Prolia and Xgeva (denosumab).” alvotech.com ↗ “Alvotech’s partner, Dr. Reddy’s Laboratories, resubmitted the US Biologics License Application for AVT03, proposed biosimilar to Prolia®/Xgeva®.” alvotech.com ↗ “Reddy’s Laboratories announced the filing acceptance of a U.S. BLA for AVT03, a proposed biosimilar to Prolia and Xgeva (denosumab).” alvotech.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03” alvotech.com ↗ |
| Filed | EU (EMA) | — | osteoporosis, cancer-related bone disease | 2024-10-10 | “the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).” alvotech.com ↗ “the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab)” alvotech.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 2 met primary | ||||||
| Phase 1 | NCT05876949 | Jul 2023 → Apr 2024 | — | Alvotech Swiss AG | Completed | Met primary |
| Phase 1 | NCT05126784 | Jun 2022 → Oct 2023 | — | Alvotech Swiss AG | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05395091 | Aug 2022 → May 2024 | postmenopausal osteoporosis | Alvotech Swiss AG | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-11-24 | Alvotech Swiss AG | Regulatory Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area alvotech.com ↗ |
| 2025-09-22 | Alvotech Swiss AG | Regulatory European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva® alvotech.com ↗
the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03 |
| 2025-09-19 | Alvotech Swiss AG | Regulatory Alvotech Announces Marketing Approval in Japan of Three New Biosimilars alvotech.com ↗ |
| 2025-03-18 | Alvotech Swiss AG | Regulatory Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva® alvotech.com ↗
The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S., |
| 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). |
| 2024-10-10 | Alvotech Swiss AG | Regulatory European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva® alvotech.com ↗
“EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe,” |
| 2024-07-02 | Alvotech Swiss AG | Results Alvotech Announces Positive Topline Results from Confirmatory Patient Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva® alvotech.com ↗
Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab) |
| 2024-01-29 | Alvotech Swiss AG | Results Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva® alvotech.com ↗
The PK study (AVT03-GL-P01), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints. |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT03 | “AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection.” NCT05395091 ↗ |
| Known as | AVT03, Biosimilar Denosumab | “AVT03, Biosimilar Denosumab” NCT05126784 ↗ |
| Known as | denosumab | “AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection.” NCT05395091 ↗ |
| Route | Subcutaneous | “will be given as single subcutaneous injection” NCT05126784 ↗ |