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# FDA Approves Sandoz’ Prolia, Xgeva Biosimilars
- URL: https://www.fdaweb.com/fda-approves-sandoz-prolia-xgeva-biosimilars/
- Published: 2024-03-05T12:00:00.000Z
- Updated: 2026-09-14T14:24:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156488

FDA has approved Sandoz’ Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Prolia (denosumab) and Sandoz’ Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Xgeva (denosumab). An agency [statement](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-prolia-and-xgeva-treat-certain-types-osteoporosis-and?utm%5Fmedium=email&utm%5Fsource=govdelivery) says Jubbonti is approved for the same treatment indications as Prolia, while Wyost is approved for the approved Xgeva indications.

The statement says approval of Jubbonti and Wyost was based on a comprehensive review of evidence demonstrating the products are highly similar to Prolia and Xgeva and that there are no clinically meaningful differences between the two product pairs.

The side effects and adverse events observed in trials of Jubbonti and Wyost were consistent with those observed with Prolia and Xgeva, FDA says.

An agency 1/19 [Drug Safety Communication](https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease?ref=fdaweb.com) said FDA had added a Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking Prolia for osteoporosis. A similar Boxed Warning is part of the Jubbonti labeling, it says.