Seamless coverage and
support when starting or switching your patients to WYOST®

Support services, helpful forms, and FAQs about WYOST

WYOST has the SAME Medicare Part B coverage as Xgeva® (denosumab)

No step edit

No prior authorization necessary

WAC-based reimbursement

WAC=wholesale acquisition cost.

Comprehensive support services for you and your patients

WYOST co-pay card is available for eligible, commercially insured patients

Co-pay support

Eligible, commercially insured patients may pay as little as $0 for WYOST.
Terms and Conditions apply.a

ENROLL FOR CO-PAY ASSISTANCE

WYOST Co-pay Terms and Conditions: Limitations apply. Valid only for those with private commercial insurance. Prescription must be for an approved indication. Restrictions, including monthly and/or annual maximums may apply. Patient is responsible for any costs once program limit is reached. Program not valid (i) if prescription for WYOST is paid, in whole or in part, under Medicare (including Part D, even in the coverage gap), Medicaid, Medigap, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient's insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient's insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. It is a violation of the terms and conditions of this program to use it to enroll patients for the purposes of a copay accumulator or maximizer program. Sandoz reserves the right to take any appropriate action against any person or entity using the program in violation of the terms and conditions. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and US Territories (Puerto Rico, Guam, Northern Mariana Islands, and Virgin Islands). This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Co-pay program has no cash value. Additional terms and conditions may apply. Sandoz reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

Reimbursement support and benefits verification

Sandoz One Source Case Managers provide expert assistance with benefit verification and investigation, prior authorizations, appeals, and billing and coding

HCP portal

A centralized hub with access to a wealth of resources and tools to streamline support

REGISTER FOR AN ACCOUNT

Adherence support

Text message reminders for patients and injection tracking for providers via the HCP Portal

Sandoz Patient Assistance (SPA)

Support for eligible uninsured or underinsured patients seeking financial assistance for WYOST

Multiple ways to enroll your patients

Enroll online

Complete the online Sandoz One Source Enrollment Form for WYOST.

Enroll via fax

Download and fax the completed Sandoz One Source Enrollment Form to 1-833-671-1084.

Enroll via HCP portal

Register online to enroll.

Questions? Call Sandoz One Source

For questions, assistance, or more information, contact Sandoz One Source at 1-800-954-9128 to speak to a Case Manager today.

WYOST forms and resources

These downloadable forms are available to help you enroll patients in Sandoz One Source, streamline the appeal process, and track patient injections.

Patient Enrollment Form

DOWNLOAD

Letter of Medical Necessity

DOWNLOAD

Letter of Appeal

DOWNLOAD

In-office Tracker

DOWNLOAD

Frequently asked questions

WYOST is the first and only biosimilar interchangeable with Xgeva® (denosumab).1,2 It is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, the 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, and/or the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Yes. Biosimilars such as WYOST undergo rigorous evaluation to show that they are highly similar to and have no clinically meaningful differences from their reference product when it comes to safety, efficacy, and quality.3 Additionally, WYOST is the first and only biosimilar interchangeable with Xgeva®.1,2

An interchangeable biosimilar has met additional requirements and can be substituted for its reference product at the pharmacy level, depending on state pharmacy laws.3

Yes. WYOST is the first and only bone-targeting biosimilar interchangeable with Xgeva®.1,2

Extrapolation is a process by which a biosimilar is approved for indications in which it was not directly studied. If the totality of evidence demonstrates biosimilarity to the reference product in 1 indication, the biosimilar manufacturer may apply for the approval of additional indications.4

The manufacturer must work with the FDA to determine what data are needed to support extrapolation, and typically must provide scientific justification including knowledge about the MOA, PK, PD, efficacy, safety, and immunogenicity of the reference product in each of its approved indications.4

Extrapolation is critical for biosimilars since they are approved by the FDA through an abbreviated pathway, which allows them to be more cost effective and accessible than reference products.4

MOA=mechanism of action; PD=pharmacodynamics; PK=pharmacokinetics.

  • WYOST provides what you and your patients have come to expect from denosumab in terms of safety, efficacy, and immunogenicity
  • Sandoz One Source offers support services to you, your patients, and your staff, as well as financial support options for eligible patients
  • WYOST is backed by Sandoz, a global leader in biosimilars with 25+ years of experience5

Yes. Through the co-pay program, eligible patients may pay as little as $0 for WYOST. Additional resources may be available through Sandoz One Source for patients who do not qualify for the co-pay program.

A biosimilar is a biologic that is highly similar to and has no clinically meaningful differences from an existing FDA-approved product, called a reference product.3 Biosimilars are rigorously evaluated by the FDA to show that there are no differences in safety, efficacy, or quality compared with the reference product. Patients can start biologic treatment with a biosimilar or transition from the reference product.3

Biosimilars offer comparable efficacy and safety to their reference products and increase access by reducing costs.5

Prescribing biosimilars has resulted in:

  • $36 billion in savings since 20156
  • $12.4 billion in savings in 2023 alone6
  • 495 million additional patient-days of treatment6
  • ~45% lower out-of-pocket costs for patients who used certain biosimilars instead of reference products7

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

Backed by Sandoz

Sandoz is a global leader in biosimilars with 25+ years of experience.

SEE OUR STORY
Important Safety Information and Indications
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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. WYOST. Prescribing information. Sandoz Inc. 2. US Food and Drug Administration. FDA Approves First Interchangeable Biosimilars to Prolia and Xgeva to Treat Certain Types of Osteoporosis and Prevent Bone Events in Cancer. 2024. Accessed March 6, 2025. https​:​//​www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-prolia-and-xgeva-treat-certain-types-osteoporosis-and 3. US Food and Drug Administration. Biosimilar Regulatory Review and Approval. Accessed March 6, 2025. https​:​//​www.fda.gov/media/151061/download?attachment 4. US Food and Drug Administration. Biosimilar Regulatory Review and Approval. Accessed March 6, 2025. https​:​//​w​w​w​.​fda​.​gov​/​files​/​drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf 5. Sandoz website. Accessed March 6, 2025. https://www.sandoz.com 6. Association for Accessible Medicines. The U.S. Generic & Biosimilar Medicines Savings Report. September 2024. Accessed March 6, 2025. https​:​//​accessiblemeds​.​org​/​wp-content​/​uploads/2025/01/AAM-2024-Generic-Biosimilar-Medicines-Savings-Report.pdf 7. Socal M, Ballreich J, Chyr L, Anderson G. Biosimilar medications – Savings opportunities for large employers. Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management; 2020. Accessed March 6, 2025. https://www.eric.org/wp-content/uploads/2020/03/JHU-Savings-Opportunities-for-Large-Employers.pdf

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