Wyost and Jubbonti Launch as First Denosumab Biosimilars in the US

The US pharmaceutical market has witnessed the launch of the first denosumab biosimilars, Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking a significant development for patients and health care systems.1 These products are now available for use across all indications of their reference medicines, Xgeva (denosumab) and Prolia (denosumab), respectively.

These biosimilars were originally approved in March 2024 and were also approved with interchangeability, meaning that they can be substituted in place of their respective reference agents (Wyost to Xgeva; Jubbonti to Prolia) at the pharmacy level without waiting for a physician to approve the switch.2

Denosumab is a critical therapeutic agent used to manage conditions such as osteoporosis and cancer-related skeletal events. Osteoporosis, a condition characterized by weakened bones, affects more than 10 million US adults 50 years or older, with many more at risk.3 Bone metastases, where cancer cells spread to the bone, impact approximately 330,000 individuals in the US, often leading to painful skeletal-related events and fractures.4

Keren Haruvi, president of Sandoz’ North America division, commented on the significance of this launch. "Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients," he stated.

The availability of these biosimilars is anticipated to introduce increased competition within the denosumab market, which could contribute to greater affordability for patients and health care payers. Both Wyost and Jubbonti are designed to have the same dosage form, route of administration, dosing regimen, and presentation as their reference medicines. Additionally, these new biosimilars will launch with an established Q code, which is expected to facilitate reimbursement processes.

Organizations focused on patient advocacy have welcomed the development. Claire Gill, CEO of the Bone Health and Osteoporosis Foundation, noted the potential positive impact. "Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve," Gill said.

Support resources for patients prescribed Wyost and Jubbonti, including reimbursement and financial assistance programs, are also being provided. The entry of these interchangeable denosumab biosimilars into the US market signifies the potential for wider availability of more affordable treatment options for patients requiring denosumab therapy.

References

1. Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients. Sandoz. June 2, 2025. Accessed June 2, 2025. https://www.sandoz.com/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-us-providing-new-affordable/

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars®. March 5, 2024. Accessed June 2, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Osteoporosis: from the FDA Office of Women's Health. FDA. Updated May 13, 2024. Accessed June 2, 2025. https://www.fda.gov/consumers/womens-health-topics/osteoporosis

4. Bone metastasis. Moffitt Cancer Center. Accessed June 2, 2025. https://www.moffitt.org/cancers/bone-metastasis/