The Denosumab Revolution: Why the Biosimilar Market for Prolia® and Xgeva® Is Exploding

It’s been more than ten years since the Food and Drug Administration (FDA) approved the first biosimilar product in the United States. Since that time, roughly 75 biosimilars have been approved for 20 reference products. Morris & Dickson is committed to ensuring patients and providers have access to these cost-saving biosimilars. The latest reference product to see significant change is denosumab, the active ingredient in both Prolia® and Xgeva®.

Denosumab is a RANKL inhibitor, an antibody that binds to RANKL (Receptor Activator of Nuclear factor ĸ Β Ligand). It works by preventing RANKL from interacting with the osteoclast receptor, so osteoclast activity is reduced. This means the body will more slowly break down bone tissue. Depending on the indication, denosumab is administered by a medical provider subcutaneously every four weeks or every six months.

The FDA approved the first products, Jubbonti® as interchangeable to Prolia, and Wyost® as interchangeable with Xgeva, back in March 2024. While these products didn’t launch until early June 2025, being the first products to receive interchangeability status allows them an interchangeable exclusivity through October 2025. But denosumab has seen quick growth in the biosimilar space. February and March 2025 saw the rapid approvals of additional Prolia and Xgeva biosimilars. By early July, Stoboclo® and Conexxence® joined the Prolia biosimilar portfolio and Osenvelt® and Bomyntra® had joined that of Xgeva. One additional manufacturer has received FDA approval but has not yet launched their denosumab biosimilar products in the United States. Experts predict this market may grow quickly and see up to ten or fifteen biosimilar products approved by the end of 2026, with up to 83% biosimilar dispense rate for Prolia and 98% for Xgeva biosimilars in the next four years. 

Morris & Dickson is pleased to announce that, in addition to the originator products, Prolia and Xgeva, customers now also have access to the entire portfolio of denosumab biosimilars that are available today. Members of our group purchasing organization, BeaconMD, also have access to reduced pricing for Jubbonti, Osenvelt, Stoboclo, and Wyost.

 As biosimilars continue to gain acceptance among patients, providers, and payers, we understand these products are a critical part of a sustainable healthcare system. By ensuring a robust portfolio, we are helping pharmacies evolve to the market demands and support patients at every stage of life.

Reach out to your Morris & Dickson sales representative for more information or to access additional biosimilar products.