Catalyst overview
Research summary
This catalyst tracks a Approved quarterly sales for Denosumab Biosimilars in Osteoporosis. The expected timing is based on the latest available company guidance and may change.
Denosumab biosimilar candidates reference Prolia® and XGEVA®. 3/4/25- BLA accepted. PDUFA target action date Q4 2025. 8/7/25- Ongoing development. 12/22/25:- FDA approved Boncresa and Oziltus denosumab biosimilars. Prolia/XGEVA U.S. sales ~$5.3B annually. 02/27/26:- PR No update. 05/07/26:- PR No update. 07/30/26:- PR No update.
Verification
Confirm timing and program details against the company announcement or filing.