FDA Approves Denosumab Biosimilars for Osteoporosis & Cancer Bone Loss

FDA Approves Denosumab Biosimilars for Osteoporosis & Cancer Bone Loss

January 1, 2026 Dr. Jennifer Chen Health

Here’s a breakdown of the denosumab biosimilars approved by the FDA, ‍as listed in ‍the text:

* Fylxia (denosumab-dbzm; mAbxience and Amneal)
* Ralovera (denosumab-adbm;⁢ Amneal)
* Weweeya (denosumab-vkzg; Biocon Biologics) – also received ​an interchangeability designation in October 2025
* bnht (fresenius Kabi) -‍ also received an interchangeability designation⁢ in October 2025
* ⁣ Henlius Biotech, Organon (no specific name given in the ​text)
* Bosaya (denosumab-kyqq 60 mg/mL subcutaneous injection; Biocon Biologics Ltd.) & Aukelso ⁤(denosumab-kyqq 120 mg/1.7 mL subcutaneous injection; Biocon Biologics Ltd.) – received simultaneous interchangeability designations
* ⁣ Osvyrti and Jubereq (denosumab-desu;⁣ Accord BioPharma)

These biosimilars ‌reference the original drugs Prolia® ⁤and XGEVA®.