Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVT03 · 1 trial · 1 indication
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
| Arm | Type | Description |
|---|---|---|
| AVT03 | EXPERIMENTAL | AVT03 is the proposed biosimilar for Prolia. |
| Prolia | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AVT03 | BIOLOGICAL | AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg. |
| Denosumab | BIOLOGICAL | Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection. Subjects in this arm received 60mg of commercially available US-Prolia, administered s.c on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group were re-randomized in a 1:1 ratio to receive either: * AVT03 60 mg administered s.c. on Day365. * Prolia 60 mg administered s.c. on Day365. |
1. Postmenopausal women with osteoporosis willing to sign an informed consent form (ICF)and able to undergo protocol related procedures. 2. A baseline dual-energy x-ray absorptiometry (DXA) scan with a T score ≤-2.5 and * 4.0 at the LS (L1 to L4)and/or, total hip, and/or femoral neck. 3. Age: ≥5...
AVT03 is an investigational monoclonal antibody developed by Alvotech as a proposed biosimilar to denosumab. It is being studied for the treatment of postmenopausal osteoporosis, a condition in which bone density decreases after menopause. AVT03 is a Phase 3 candidate and has not been approved by the FDA.
AVT03 is being developed for postmenopausal osteoporosis, the bone-thinning condition that affects women after menopause. Its clinical program has focused on this indication, with a Phase 3 study conducted in postmenopausal women aged 50 years and older. AVT03 remains investigational and is not approved for any use.
AVT03 targets denosumab, meaning it is designed as a biosimilar version of the denosumab monoclonal antibody. Denosumab is a protein therapeutic that acts on the RANK ligand pathway to reduce bone resorption. AVT03 is intended to match the reference denosumab product rather than act through a novel mechanism.
AVT03 is developed by Alvotech, a biotechnology company that trades on the Nasdaq under the ticker ALVO. Alvotech specializes in the development and manufacture of biosimilar medicines. AVT03 is one of the company's monoclonal antibody biosimilar candidates.
AVT03 is in Phase 3 development. Its single registered trial, ALVOBOND, was a Phase 3 study that has been completed. AVT03 is an investigational product and has not been approved by the FDA for postmenopausal osteoporosis or any other indication.
AVT03 has been evaluated in one clinical trial, NCT05395091, also called ALVOBOND. This completed Phase 3 study was a multicenter, randomized, double-blind, active-controlled trial that enrolled 532 postmenopausal women with osteoporosis across Bulgaria, Czechia, Georgia, Poland, and South Africa.