Drug Profile

Denosumab biosimilar - Alvotech

Alternative Names: AVT-03-Alvotech; AVT03

Latest Information Update: 02 Apr 2025

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At a glance

Originator Alvotech
Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
Mechanism of Action Antibody-dependent cell cytotoxicity; RANK ligand inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Preregistration Postmenopausal osteoporosis

Most Recent Events

18 Mar 2025 Preregistration for Postmenopausal osteoporosis in USA (SC), prior to March 2025
10 Oct 2024 Preregistration for Postmenopausal osteoporosis in European Union (SC)
10 Oct 2024 EMA accepts MAA for Denosumab biosimilar for Postmenopausal osteoporosis for review

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