Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy

- Sandoz, a Novartis division, received FDA approval for Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz).
- These biosimilars are the first FDA-approved alternatives to Amgen's blockbuster bone-preserving therapy denosumab, sold as Prolia and Xgeva.
- Wyost is intended for preventing skeletal-related events in multiple myeloma and bone metastasis patients, along with treating giant cell tumor of bone and hypercalcemia of malignancy resistant to bisphosphonates.
- Jubbonti is approved for various osteoporosis-related uses, including increasing bone mass in specific populations and managing glucocorticoid-induced osteoporosis.
- Both biosimilars share the same dosage forms, routes of administration, dosing regimens, presentations, and indications as their reference products.
- Jubbonti and Wyost hold interchangeability designations, permitting substitution without altering the original prescription.
- Launch dates and pricing remain undisclosed due to ongoing patent litigation.