WYOST® can help deliver on the value of biosimilars and may offer cost savings to the healthcare system and to patients

Since FDA approval in 2010, Amgen has raised the price of
Xgeva® (denosumab) 20 times, more than doubling the cost

Annual wholesale acquisition cost showed that Amgen nearly doubled Xgeva® (denosumab) WAC since FDA approval in 2010 Annual wholesale acquisition cost showed that Amgen nearly doubled Xgeva® (denosumab) WAC since FDA approval in 2010

Cost per vial has risen from $1,650 to $3,449.

The rising cost of reference denosumab

In 2022, Medicare Part B spent over

$2 BILLION

on reference denosumab, accounting for 5% of all Medicare Part B spending, with the price rising faster than the rate of inflation2,3b

ICER listed Xgeva® as one of the

TOP 10

drugs with unsupported net price increases in 2022 for its impact on US health expenditures4

Metastatic bone disease (MBD) is costly in oncology

Prevalence

>2 MILLION

new cancer cases are expected to be diagnosed in the United States annually5

Treatment Cost

17%

of all oncology direct medical costs in the United States can be attributed to MBD6

Skeletal-related events (SREs) are associated with higher healthcare
resource utilization7c

EMERGENCY DEPARTMENT VISITS

Emergency department visits are almost 2 times more frequent in skeletal-related eventsEmergency department visits are almost 2 times more frequent in skeletal-related events

HOSPITAL
ADMISSION

Hospital admission is 2.2 times more likely in skeletal-related events Hospital admission is 2.2 times more likely in skeletal-related events

HOSPITAL
STAY

Hospital stays are 7 days longer in skeletal-related events Hospital stays are 7 days longer in skeletal-related events

OUTPATIENT
CARE

Outpatient care is 1.6 times more likely to require outpatient hospital visits Outpatient care is 1.6 times more likely to require outpatient hospital visits

a Wholesale acquisition cost is the manufacturer’s list price to wholesalers/direct purchasers and does not include discounts to payers, providers, distributors, or other purchasing organizations. Data as of January 2025.

b Costs are based on Prolia® (denosumab).

c This retrospective, observational cohort study used IBM Watson Health MarketScan commercial and Medicare claims data from 2007 to 2015 to assess the healthcare burden of SREs in patients with bone metastases naïve to prophylactic treatment. After propensity score matching, 10,827 patients with SREs were matched to 10,827 non-SRE controls. The analysis focused on healthcare resource use and costs among matched patients with and without SREs during the follow-up period. Costs were derived from various services, including inpatient admissions, emergency room visits, outpatient office visits, other outpatient services, and pharmacy prescriptions, reported as per-patient per-year (PPPY) units in 2016 US dollars (adjusted for inflation). Limitations included potential misclassification and underestimation of clinical conditions due to reliance on claims data, incomplete capture of deaths outside inpatient settings, exclusion of certain treatments, and residual bias despite propensity score matching.

ICER=Institute for Clinical and Economic Review; WAC=wholesale acquisition cost.

Confirmed biosimilarity

Review the totality of evidence for WYOST, including results from the phase 3 ROSALIA study.

DISCOVER THE DATA

Identical dosing

WYOST has the same dosing and administration as Xgeva®.

SEE DOSING
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Important Safety Information and Indications
icon-caret-up
INDICATIONS

  • WYOST (denosumab-bbdz) is indicated for:

  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
  • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
IMPORTANT SAFETY INFORMATION

  • CONTRAINDICATIONS

  • Hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with WYOST.
  • Hypersensitivity: WYOST is contraindicated in patients with known clinically significant hypersensitivity to denosumab products.

  • WARNINGS AND PRECAUTIONS

  • Drug Products with Same Active Ingredient

  • Patients receiving WYOST should not receive other denosumab products concomitantly.

  • Hypersensitivity

  • Clinically significant hypersensitivity including anaphylaxis has been reported with use of denosumab products. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue WYOST therapy permanently.

  • Hypocalcemia

  • Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to WYOST treatment. Monitor calcium levels, throughout WYOST therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare provider for symptoms of hypocalcemia
  • An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

  • Osteonecrosis of the Jaw (ONJ)

  • ONJ has been reported in patients receiving denosumab products, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure. Risk factors include a history of tooth extraction, poor oral hygiene, or use of a dental appliance. Other risk factors include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections, and a history of invasive dental procedures for denosumab-treated patients with multiple myeloma.
  • Perform an oral examination and appropriate preventive dentistry prior to the initiation of WYOST and periodically during WYOST therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with WYOST. Consider temporary discontinuation of WYOST therapy if an invasive dental procedure must be performed.
  • Patients who are suspected of having or who develop ONJ while on WYOST should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery may exacerbate the condition.

  • Atypical Subtrochanteric and Diaphyseal Femoral Fracture

  • Atypical femoral fracture has been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.
  • Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture.
  • During WYOST treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of WYOST therapy should be considered, pending a risk/benefit assessment, on an individual basis.

  • Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons

  • Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab product-treated patients with GCTB and patients with growing skeletons within the first year after treatment discontinuation. After treatment is discontinued, monitor patients for signs and symptoms of hypercalcemia and manage patients as clinically appropriate.

  • Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation

  • MVF have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When WYOST treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures

  • Embryo-Fetal Toxicity

  • Based on data from animal studies and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman.
  • Advise females of reproductive potential to use effective contraception during therapy and for at least 5 months after the last dose of WYOST. Advise pregnant women and females of reproductive potential that exposure to WYOST during pregnancy or within 5 months prior to conception can result in fetal harm.

  • ADVERSE REACTIONS

  • The most common adverse reactions (incidence ≥25%) in patients receiving denosumab with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation of denosumab were osteonecrosis and hypocalcemia.
  • The most common adverse reactions in patients receiving denosumab with multiple myeloma (incidence ≥10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction (incidence ≥5%) was pneumonia. The most common adverse reaction resulting in discontinuation of denosumab (≥1.0%) was osteonecrosis of the jaw.
  • The most common adverse reactions in patients receiving denosumab with giant cell tumor of bone (incidence ≥10%) were arthralgia, back pain, pain in extremity, fatigue, headache, nausea, nasopharyngitis, musculoskeletal pain, toothache, vomiting, hypophosphatemia, constipation, diarrhea, and cough. The most frequent serious adverse reactions were osteonecrosis of the jaw (3.6%), bone giant cell tumor (1.5%), anemia (1.1%), pneumonia (0.9%), and back pain (0.9%). The most frequent adverse reactions resulting in discontinuation of denosumab was osteonecrosis of the jaw (incidence of 3.6%). The adverse reaction profile appeared similar in skeletally mature adolescents and adults.
  • Adverse reactions occurring in >20% of patients receiving denosumab with hypercalcemia of malignancy were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. The following adverse reactions of Grade 3 or greater severity related to study therapy were reported on-study: fatigue (3%) and infection (6%). Grade 3 laboratory abnormalities included hypomagnesemia (3%), hypokalemia (3%), and hypophosphatemia (76%) of patients. No deaths on-study were related to denosumab therapy.

Please see full Prescribing Information for WYOST.

References: 1. Data on file. Analysource pricing grid. Sandoz Inc. June 2024 to January 2025. 2. Centers for Medicare & Medicaid Services. Medicare Part B Spending by Drug. Accessed March 6, 2025. https​:​//​data​.​cms​.​gov​/​summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug​/​medicare-part-b-spending-by-drug 3. Centers for Medicare & Medicaid Services. Reduced Coinsurance for Certain Part B Rebatable Drugs Under the Medicare Prescription Drug Inflation Rebate Program. September 2024. Accessed March 6, 2025. https​:​//​w​w​w​.​cms​.​gov​/​files​/​document​/​reduced-coinsurance-certain-part-b-rebatable-drugs-july-1-september-30-2024​.​pdf 4. Rind DM, Agboola F, Nikitin D, et al. Unsupported Price Increase Report: Unsupported Price Increases Occurring in 2022. Institute for Clinical and Economic Review. Updated December 11, 2023. Accessed March 6, 2025. https​:​//​icer​.​org​/​wp-content​/​uploads​/​2023​/​04​/​UPI_2023_Report_121123​.​pdf 5. American Cancer Society. Cancer Facts & Figures 2024. 2024. Accessed March 6, 2025. https​:​//​w​w​w​.​cancer​.​org/​content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs​.​pdf 6. Schulman KL, Kohles J. Economic burden of metastatic bone disease in the U.S. Cancer. 2007;109(11):2334-2342. doi:10.1002/cncr.22678 7. Bhowmik D, Song X, Intorcia M, Gray S, Shi N. Examination of burden of skeletal-related events in patients naive to denosumab and intravenous bisphosphonate therapy in bone metastases from solid tumors population. Curr Med Res Opin. 2019;35(3):513-523. doi:10.1080/03007995.2018.1532884

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