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)

					

