Sandoz Launches Biosimilars of Xgeva/Prolia

Sandoz has launched its interchangeable biosimilars of Amgen’s Xgeva/Prolia. Wyost and Jubbonti, approved by the FDA in March 2024, are interchangeable for the reference products and are approved for all of the same indications in bone cancer and osteoporosis and have the same dosage form, route of administration and dosing regimen as the reference medicines.

Sandoz has priced both products at $26.74/mg. This is 7% lower than Xgeva and 14.5% lower than Prolia. The company anticipates coverage of these products across most plans. Wyost and Jubbonti have the same Medicare Part B (fee for service) coverage as Prolia and Xgeva, with no step edits or prior authorization required. This accounts for 35% to 40% of the market, according to a Sandoz spokesperson.

For patients with commercial insurance, Sandoz is offering a $0 copay. The terms of this assistance indicate that it is “intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles.”

“We are working closely with our payer customers to secure access for patients,” the spokesperson said. “Our goal is to ensure broad access to this critical treatment for patients on Medicare Advantage and commercial plans as well. We are confident in being positioned favorably and expect payers’ announcements on formulary decisions to come out in the coming months.”

Additionally, Sandoz is providing support resources for patients, including reimbursement and financial support. Sandoz One Source Case Managers provide expert assistance with benefit verification and investigation, prior authorizations, appeals, and billing and coding.

Claire Gill

“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, Claire Gill, CEO of the Bone Health and Osteoporosis Foundation, said in a news release.

Related: FDA Approves First Prolia, Xgeva Biosimilars

Wyost (denosumab-bbdz), which references Xgeva, is approved to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also approved to treat adults and skeletally mature adolescents with giant cell tumor of bone and hypercalcemia of malignancy refractory to bisphosphonate therapy.

Wyost is administered subcutaneously, 120 mg every 4 weeks for multiple myeloma and bone metastasis. For giant cell tumor of bone and hypercalcemia, an additional 120 mg dose on Days 8 and 15 of the first month of therapy.

Bone is the third most frequent site for metastatic tumors. Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.

Jubbonti (denosumab-bbdz), which is a biosimilar of Prolia, is approved to treat several conditions, including men and postmenopausal women with osteoporosis. It is also approved to treat glucocorticoid-induced osteoporosis in men and women, to increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, and for women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Jubbonti is administered subcutaneously, 60 mg every six months.

Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease or when bone strength and structure change. More than 10 million U.S. adults aged 50 and over live with osteoporosis, a major cause of fractures in postmenopausal women and in older men.

Denosumab is a monoclonal antibody that slows bone resorption, which is the process by which bone tissue is broken down and released into the bloodstream. When this happens excessively, it can lead to complications such as osteoporosis and bone fractures. Osteoporosis is a natural part of aging for many women who have gone through menopause, but certain cancer treatments can also weaken bone structure.