> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts Alvotech AVT03 BLA
- URL: https://www.fdaweb.com/fda-accepts-alvotech-avt03-bla/
- Published: 2025-03-19T12:00:00.000Z
- Updated: 2026-09-14T14:55:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158852

FDA has accepted a BLA submitted by Dr. Reddy’s Laboratories and Alvotech for AVT03, developed by Alvotech as a biosimilar of Amgen’s Prolia (denosumab) and Xgeva (denosumab). A statement from the companies says AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia, indicated to treat osteoporosis in postmenopausal women and for bone loss in men and women at increased risk of fracture, and Xgeva, indicated to prevent skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone.