Further Integrating Biosimilars into Oncology: The Role of WYOST (denosumab-bbdz) in Preventing Cancer-Related Skeletal Events with Bone Metastases from Solid Tumors

Managing bone metastases remains a critical aspect of comprehensive cancer care. Skeletal-related events (SREs), including fractures or spinal compression, can significantly disrupt the treatment journey. Preventing and managing SREs is essential in optimizing cancer care.

The Burden of SREs

SREs are most commonly seen in the estimated 330,000 people in the US currently living with bone metastases from breast, prostate, lung, kidney and thyroid cancers.1 These SREs can cause severe pain, limit mobility, and often interrupt cancer treatment—surgery for a fracture, for example, may require pausing chemotherapy. Moreover, experiencing one SRE significantly increases the risk of future occurrences.2 Additionally, the high cost of treatment remains a barrier. For those lacking comprehensive health insurance or facing steep out-of-pocket costs, the financial burden can delay treatment, undermine adherence, and lead to discontinuation.3

While there are effective treatments to help prevent SREs for certain types of cancer, access and affordability remain barriers for many patients. This is where biosimilars, like WYOST®, can make a meaningful difference—offering a more accessible, cost-effective option.

“Skeletal-related events are a challenging complication of bone metastases,” said Claire Gill, CEO, the Bone Health and Osteoporosis Foundation. “They may cause significant discomfort and interfere with a patient’s ability to continue their cancer treatment as planned. Reducing the risk of these events is vital and expanding access to effective therapies plays a key role in delivering equitable cancer care.”

Introducing WYOST®: The First Interchangeable Denosumab Biosimilar

Biosimilars can improve treatment accessibility and support continuity of care, including for patients managing complex conditions like SREs in cancer.4

WYOST® has been approved by the FDA as the first interchangeable biosimilar to XGEVA®* (denosumab). It is a human monoclonal antibody designed to bind to the RANKL protein, which is an activator of osteoclasts, a type of cell involved in breaking down bone tissue.5,6 WYOST® is approved for all indications, including the prevention of SREs. The interchangeability designation means this biosimilar may be substituted for the reference product without the intervention of the prescribing health care provider, depending on state pharmacy laws.

Why WYOST®, Why Now?

The launch of WYOST® brings several advantages to patients and providers:

• Same dosing and administration as the reference medicine (120 mg/1.7 mL injection)
• Permanent Q code for reimbursement clarity
• Backed by comprehensive support services from Sandoz, including insurance support, benefit investigation, and injection assistance

This kind of broadened access matters. For those living with cancer, having access to biosimilars like WYOST® may mean one less financial barrier to receiving critical care. For oncologists, it offers confidence in treatment continuity without compromising clinical efficacy.

Sandoz, the company behind WYOST®, is a global leader in biosimilars with 25+ years of experience. With two dozen biosimilars in various stages of development and 11 biosimilars already on the market, Sandoz is helping reshape what access and affordability can look like.

As value-based models and cost containment become more central to oncology care delivery, biosimilars like WYOST® are an essential part of the solution. For oncology teams focused on maintaining treatment continuity and reducing the burden of SREs, WYOST® offers another option and represents a meaningful step toward more equitable cancer care for those who need it most.

*XGEVA® is a registered trademark of Amgen Inc.

IMPORTANT SAFETY INFORMATION

Do not take WYOST if you:

• have low blood calcium (hypocalcemia). Your low blood calcium must be treated before you receive WYOST. Denosumab products can significantly lower the calcium levels in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.
• are allergic to denosumab or any of the ingredients of WYOST. Serious allergic reactions have happened in people who take denosumab products. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.

What is the most important information you should know about WYOST?

If you receive WYOST, you should not receive other denosumab products.

Severe jaw bone problems (osteonecrosis)

Severe jaw bone problems may happen when you take denosumab products. Your doctor should examine your mouth before you start, and while you are taking WYOST. Tell your dentist that you are taking WYOST. It is important for you to practice good mouth care during treatment with WYOST. In studies of patients with bone involvement, the rate of severe jaw problems was higher the longer they were being treated with denosumab.

Unusual thigh bone fracture

Unusual thigh bone fracture has been reported with denosumab products. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Risk of high calcium levels following treatment discontinuation in patients with giant cell tumor of bone and in patients who are still growing

Patients with a type of cancer called giant cell tumor of bone and patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after they stop taking WYOST, which can be serious.

Increased risk of broken bones in the spine after discontinuing WYOST

After your treatment with WYOST is stopped, your risk for breaking bones in your spine can increase, especially if you have a history of risk factors such as osteoporosis or prior fractures.

Possible harm to your unborn baby

You should not become pregnant while taking WYOST. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. WYOST can harm your unborn baby.

Tell your doctor if you:

• Are taking another denosumab product.
• Have symptoms of low blood calcium such as muscle stiffness or cramps
• Have symptoms of severe jaw bone problems such as pain or numbness
• Have ongoing pain or slow healing after dental surgery
• Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
• Are pregnant, plan to become pregnant, suspect you are pregnant, or are breastfeeding

While taking WYOST, you should:

• Tell your doctor about all medications you are taking. Your doctor needs to know if you are taking other medications that also lower blood calcium levels
• Take good care of your teeth and gums and visit a dentist as recommended
• Tell your dentist that you are taking WYOST
• Tell your doctor if you plan to have dental surgery or teeth removed
• Talk to your doctor before you stop taking WYOST about your risk for broken bones in your spine
• Women of childbearing age should use highly effective contraception while taking WYOST and for at least 5 months after the last dose of WYOST

What are the possible side effects of WYOST?

In patients with bone metastases from solid tumors receiving denosumab, the most common side effects were tiredness/weakness, low phosphate levels in their blood, and nausea. The most common serious side effect of denosumab was shortness of breath.

In multiple myeloma patients receiving denosumab, the most common side effects were diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction in multiple myeloma patients was pneumonia.

In patients with giant cell tumor of bone receiving denosumab, the most common side effects were pain in the joints, back pain, pain in extremities, fatigue, headache, nausea, common cold, pain in the muscles and joints, toothache, vomiting, low phosphate levels, constipation, diarrhea, and cough. The most frequent serious adverse reactions were severe jaw bone problems, bone giant cell tumor, low red blood cells, pneumonia, and back pain. The most frequent adverse reactions resulting in discontinuation of denosumab were severe jaw bone problems. The adverse reaction profile appeared similar in skeletally mature adolescents and adults.

In patients with hypercalcemia of malignancy receiving denosumab, the most common side effects were nausea, shortness of breath, decreased appetite, headache, swelling of the lower legs or hands, vomiting, low red blood cells, constipation, and diarrhea. The following adverse reactions of Grade 3 or greater severity related to study therapy were reported on-study: fatigue and infection. Grade 3 laboratory abnormalities included low magnesium levels, low potassium levels, and low phosphate levels. No deaths on-study were related to denosumab therapy.

Please click to see full Prescribing Information for Wyost.

References

1. Moffitt Cancer Center. Bone Metastasis. Available at: https://www.moffitt.org/cancers/bone-metastasis/ [Last accessed: July 2025]
2. Multiple Myeloma Patients and Risk of Skeletal Related Events - Real-World Evidence in US Oncology Clinics. Available at: https://ashpublications.org/blood/article/130/Supplement%201/2171/71307/Multiple-Myeloma-Patients-and-Risk-of-Skeletal [Last accessed: July 2025]
3. National Cancer Institute. Financial Toxicity and Cancer Treatment (PDQ®) Patient Version. Available at: https://www.cancer.gov/about-cancer/managing-care/track-care-costs/financial-toxicity-pdq [Last accessed: July 2025]
4. Food and Drug Administration. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Available at: https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars [Last accessed: July 2025]
5. Food and Drug Administration. XGEVA® (Ustekinumab): Medication Guide. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf [Last accessed: July 2025]
6. WYOST®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: July 2025]