U.S. License Holder:
Alvotech / Dr. Reddy's
Date of License:
aBLA accepted by FDA March-2025
Last Update:
Sep-30-2025
FDA-Approved Indications
AVT03 (denosumab) is not FDA-approved. An aBLA has been accepted by the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Japan
AVT03 (Alvotech / Fuji Pharma) (September-2025)