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What are biosimilars?

OSENVELT is a prescription biosimilar of Xgeva® (denosumab). Biosimilar means that:

  • A biologic product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product
  • There are no clinically meaningful differences in how it works or in how safe it is compared to the reference product

A biosimilar is typically more affordable than the reference product.

Since OSENVELT is a biosimilar of Xgeva, it can be used instead of Xgeva.

Like Xgeva, OSENVELT works to protect bones from cancer-related damage

Certain cancers can affect the way your bones stay strong by speeding up bone breakdown. This can increase your risk of serious bone problems.

OSENVELT works by blocking a natural protein in your body called RANKL. This protein signals cells that break down bones. By blocking RANKL, OSENVELT helps slow bone breakdown.

OSENVELT is not a cancer treatment.

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The medicine in OSENVELT, denosumab-bmwo, has been shown to be as effective as denosumab, the medicine in Xgeva

In people with:

  • metastatic breast cancer or castration-resistant prostate cancer, denosumab extended the time to first onset of bone complications compared with zoledronic acid
  • bone metastases due to solid tumors or multiple myeloma, denosumab was as least as good as zoledronic acid in prolonging the time to the onset of bone complications

In clinical studies of Xgeva in people whose cancer had spread to their bones, denosumab—the active ingredient in both Xgeva and OSENVELT—was compared to another medicine called zoledronic acid, which is also used to treat bone complications from cancer.

Patients who had no serious bone complications

Patients with

metastatic breast cancer

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Patients with

solid tumors or multiple myeloma

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Patients with

metastatic castrate-resistant prostate cancer

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Denosumab protected patients from serious bone complications—over 64% of patients across all uses had no serious bone complications.

Approved for multiple conditions

OSENVELT is approved for other uses similar to Xgeva, including some that weren’t directly studied. The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to a reference product, including clinical trials, blood and immune system evaluations, and chemical analyses. OSENVELT passed these tests and is an FDA-approved biosimilar to Xgeva.

OSENVELT can be used to prevent serious bone problems* in:

People with
Multiple Myeloma

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

People with
Bone Metastases
from solid tumors

People receiving treatment for
Hypercalcemia
of malignancy refractory to bisphosphonate therapy

*Serious bone problems include:

  • Broken bones
  • Problems with your bones that require surgery
  • Need for radiation treatment to the bone
  • Pressure on the spinal cord (compression)

Common side effects of OSENVELT

In people with bone metastases from breast, prostate, and other solid tumors:

  • Tiredness/weakness
  • Low phosphate levels in the blood
  • Nausea

In people with multiple myeloma:

  • Diarrhea
  • Nausea
  • Low number of red blood cells
  • Low number of blood platelets
  • Back pain
  • Low calcium levels
  • Swelling of the lower legs or hands
  • Upper respiratory tract infection
  • Rash
  • Headache

The most common serious side effect was pneumonia.

In people with giant cell tumor of bone:

  • Joint pain
  • Headache
  • Nausea
  • Back pain
  • Fatigue
  • Pain in legs, arms, or hands

These are not all the possible side effects of OSENVELT. Other side effects have been reported. It is important to be aware and look for signs and symptoms.

In people getting treatment for hypercalcemia of malignancy:

  • Nausea
  • Difficulty breathing
  • Decreased appetite
  • Headache
  • Swelling in the lower legs or hands
  • Vomiting
  • Low number of red blood cells
  • Constipation
  • Diarrhea

These are not all the possible side effects of OSENVELT. Other side effects have been reported. It is important to be aware and look for signs and symptoms.

Call your doctor for medical advice about side effects. You may report side effects to FDA at
1‑800‑FDA‑1088. You may also report side effects to Celltrion USA, Inc. at 1‑800‑560‑9414.

FDA, Food and Drug Administration.

IMPORTANT SAFETY INFORMATION

If you receive OSENVELT, you should not receive other denosumab products at the same time.

OSENVELT can cause serious side effects including:

Serious allergic reactions. Serious allergic reactions have occurred with denosumab products. Call your doctor or seek emergency care immediately if you experience symptoms such as low blood pressure (hypotension), rash, difficulty breathing, itching, throat tightness, hives, or swelling of your face, lips, or tongue.

Low blood calcium (Hypocalcemia). OSENVELT can lower your blood calcium levels, which can become severe or even life-threatening. Your doctor will check your calcium levels before and during treatment, especially in the first few weeks. You may need to take calcium, magnesium, and vitamin D supplements as instructed by your doctor. Your risk may be higher if you have kidney problems or take other medicines that lower blood calcium. Call your doctor immediately if you experience symptoms of low blood calcium, such as muscle spasms or cramps, numbness or tingling in fingers, toes, or around your mouth, twitching or stiffness.

Severe jawbone problems (osteonecrosis). Severe jaw bone problems may happen when you take OSENVELT. Your doctor should examine your mouth before starting treatment and may advise seeing a dentist. Practice good oral care and consult your doctor or dentist if needed.

Unusual thigh bone fractures. Symptoms include new or unusual pain in your hip, groin, or thigh.

High Blood Calcium After Stopping Treatment. If you have giant cell tumor of bone or are still growing, stopping OSENVELT can lead to high calcium levels in your blood (hypercalcemia). This condition can become severe, require hospitalization, and affect your kidneys. Your doctor will monitor your calcium levels after stopping treatment. Call your doctor right away if you notice symptoms of high blood calcium, such as nausea or vomiting, increased thirst or urination, confusion or tiredness, muscle weakness or pain. Follow your doctor's instructions carefully, and keep all scheduled appointments for calcium monitoring.

Multiple Spine Fractures After Stopping OSENVELT. After stopping treatment with OSENVELT, some patients have experienced multiple spine fractures. Your risk is higher if you have osteoporosis, previous fractures, or other risk factors. Your doctor will assess your individual fracture risk when stopping OSENVELT.

Risk to Unborn Babies. OSENVELT may harm your unborn baby if you take it while pregnant or within 5 months before becoming pregnant. Animal studies have shown serious harm, including pregnancy loss, birth defects, abnormal bone growth, missing lymph nodes, and slow growth after birth. Your doctor will check if you are pregnant before starting OSENVELT. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment.

Do not take OSENVELT if you have low blood calcium, are pregnant or planning pregnancy, or if you're allergic to denosumab or any ingredients in OSENVELT.

Before taking OSENVELT, tell your doctor if you:

  • take other denosumab products
  • have low blood calcium
  • cannot take daily calcium and vitamin D supplements
  • take medicines that can lower blood calcium
  • plan dental surgery or tooth removal
  • are pregnant, planning pregnancy, or breastfeeding. OSENVELT may harm an unborn baby; a pregnancy test is required before treatment; use effective birth control during treatment and for 5 months after your last dose; inform your doctor immediately if pregnancy occurs. It is unknown if OSENVELT passes into breast milk; do not breastfeed during treatment.

Tell your doctor of all medicines, vitamins, and herbal supplements you take. Keep an updated list to share with healthcare providers.

The most common side effects of OSENVELT are:

For patients with Bone Metastasis from Solid Tumors: fatigue or weakness, low phosphate levels, and nausea.

For patients with Multiple Myeloma: diarrhea, low phosphate, nausea, fatigue, low calcium, shortness of breath, and anemia.

For patients with Giant Cell Tumor of Bone: joint pain, headache, nausea, back pain, fatigue, and pain in arms or legs.

For patients with Hypercalcemia of Malignancy: nausea, trouble breathing, decreased appetite, and headache.

Tell your doctor if side effects are bothersome or persistent. These are not all possible side effects. Call your doctor for advice on side effects or report them to the FDA at 1‑800‑FDA‑1088.

Please see full Prescribing Information and talk with your healthcare provider.

INDICATIONS

OSENVELT (denosumab-bmwo) is a prescription medicine used to:

  • Help prevent bone complications in patients with multiple myeloma and in patients whose cancer from solid tumors has spread to the bones.
  • Treat adults and adolescents (whose bones have stopped growing) with giant cell tumor of bone that cannot be removed with surgery, or when surgery could cause severe complications.
  • Treat high blood calcium caused by cancer (hypercalcemia of malignancy) that has not improved after treatment with bisphosphonates.

Please see full Prescribing Information and talk with your healthcare provider.

INDICATIONS

OSENVELT® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor 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

If you receive OSENVELT, you should not receive other denosumab products at the same time.

OSENVELT can cause serious side effects including:

Serious allergic reactions. Serious allergic reactions have occurred with denosumab products. Call your doctor or seek emergency care immediately if you experience symptoms such as low blood pressure (hypotension), rash, difficulty breathing, itching, throat tightness, hives, or swelling of your face, lips, or tongue.

Low blood calcium (Hypocalcemia). OSENVELT can lower your blood calcium levels, which can become severe or even life-threatening. Your doctor will check your calcium levels before and during treatment, especially in the first few weeks. You may need to take calcium, magnesium, and vitamin D supplements as instructed by your doctor. Your risk may be higher if you have kidney problems or take other medicines that lower blood calcium. Call your doctor immediately if you experience symptoms of low blood calcium, such as muscle spasms or cramps, numbness or tingling in fingers, toes, or around your mouth, twitching or stiffness.

Severe jawbone problems (osteonecrosis). Severe jaw bone problems may happen when you take OSENVELT. Your doctor should examine your mouth before starting treatment and may advise seeing a dentist. Practice good oral care and consult your doctor or dentist if needed.

Unusual thigh bone fractures. Symptoms include new or unusual pain in your hip, groin, or thigh.

High Blood Calcium After Stopping Treatment. If you have giant cell tumor of bone or are still growing, stopping OSENVELT can lead to high calcium levels in your blood (hypercalcemia). This condition can become severe, require hospitalization, and affect your kidneys. Your doctor will monitor your calcium levels after stopping treatment. Call your doctor right away if you notice symptoms of high blood calcium, such as nausea or vomiting, increased thirst or urination, confusion or tiredness, muscle weakness or pain. Follow your doctor's instructions carefully, and keep all scheduled appointments for calcium monitoring.

Multiple Spine Fractures After Stopping OSENVELT. After stopping treatment with OSENVELT, some patients have experienced multiple spine fractures. Your risk is higher if you have osteoporosis, previous fractures, or other risk factors. Your doctor will assess your individual fracture risk when stopping OSENVELT.

Risk to Unborn Babies. OSENVELT may harm your unborn baby if you take it while pregnant or within 5 months before becoming pregnant. Animal studies have shown serious harm, including pregnancy loss, birth defects, abnormal bone growth, missing lymph nodes, and slow growth after birth. Your doctor will check if you are pregnant before starting OSENVELT. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment.

Do not take OSENVELT if you have low blood calcium, are pregnant or planning pregnancy, or if you're allergic to denosumab or any ingredients in OSENVELT.

Before taking OSENVELT, tell your doctor if you:

  • take other denosumab products
  • have low blood calcium
  • cannot take daily calcium and vitamin D supplements
  • take medicines that can lower blood calcium
  • plan dental surgery or tooth removal
  • are pregnant, planning pregnancy, or breastfeeding. OSENVELT may harm an unborn baby; a pregnancy test is required before treatment; use effective birth control during treatment and for 5 months after your last dose; inform your doctor immediately if pregnancy occurs. It is unknown if OSENVELT passes into breast milk; do not breastfeed during treatment.

Tell your doctor of all medicines, vitamins, and herbal supplements you take. Keep an updated list to share with healthcare providers.

The most common side effects of OSENVELT are:

For patients with Bone Metastasis from Solid Tumors: fatigue or weakness, low phosphate levels, and nausea.

For patients with Multiple Myeloma: diarrhea, low phosphate, nausea, fatigue, low calcium, shortness of breath, and anemia.

For patients with Giant Cell Tumor of Bone: joint pain, headache, nausea, back pain, fatigue, and pain in arms or legs.

For patients with Hypercalcemia of Malignancy: nausea, trouble breathing, decreased appetite, and headache.

Tell your doctor if side effects are bothersome or persistent. These are not all possible side effects. Call your doctor for advice on side effects or report them to the FDA at 1‑800‑FDA‑1088.

Please see full Prescribing Information and talk with your healthcare provider.

INDICATIONS

OSENVELT (denosumab-bmwo) is a prescription medicine used to:

  • Help prevent bone complications in patients with multiple myeloma and in patients whose cancer from solid tumors has spread to the bones.
  • Treat adults and adolescents (whose bones have stopped growing) with giant cell tumor of bone that cannot be removed with surgery, or when surgery could cause severe complications.
  • Treat high blood calcium caused by cancer (hypercalcemia of malignancy) that has not improved after treatment with bisphosphonates.

Please see full Prescribing Information and talk with your healthcare provider.