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# Interchangeability Status on Celltrion Biosimilars
- URL: https://www.fdaweb.com/interchangeability-status-on-celltrion-biosimilars/
- Published: 2025-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:25:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160141

FDA has granted interchangeability designations to Celltrion’s denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), making them fully substitutable at the pharmacy level for Amgen’s reference biologics Prolia and Xgeva, respectively. The action marks the first time interchangeable status has been awarded to biosimilar versions of denosumab, a monoclonal antibody widely used to treat osteoporosis and prevent skeletal-related events in cancer patients, according to Celltrion.

The company says FDA’s interchangeability determination was supported by a package of comparative analytical, pharmacokinetic, efficacy, safety, and immunogenicity data, including results from a Phase 3 study in postmenopausal women with osteoporosis. Stoboclo (approved for osteoporosis indications) and Osenvelt (for oncology-related bone loss) were originally launched in July.

Denosumab is a RANK ligand inhibitor used to reduce bone resorption and strengthen bone mass in conditions ranging from postmenopausal osteoporosis to metastasis-related bone destruction.