For US healthcare professionals only

Why prescribe OSENVELT?

OSENVELT is an FDA-approved biosimilar of Xgeva, with similar indications, dosing and administration, and MOA1*

Comparable efficacy and safety to Xgeva2

OSENVELT offers similar indications, dosage form, and strength as Xgeva so you can integrate OSENVELT into your existing protocol in its place1,3

Backed by Celltrion’s patient and practice support programs

Manufactured by Celltrion, a global leader in biopharmaceuticals

FDA, Food and Drug Administration; MOA, mechanism of action.

Denosumab-bmwo strengthened bones over 78 weeks—similar to reference denosumab2

All treatment groups demonstrated significant change over baseline at the end of the trial2

Explore the Results

Percent change from baseline in lumbar spine BMD over 78 weeks2

  • Percent change from baseline in lumbar spine BMD by DXA at week 52 was assessed as the primary endpoint2
  • Based partly on the findings of this study, OSENVELT has been approved as biosimilar to Xgeva across all Xgeva indications, including 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; and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to the reference product, including clinical trials, blood and immune system evaluations, and chemical analyses. OSENVELT passed those tests and is officially biosimilar to Xgeva1-4
Explore Results

BMD, bone mineral density; DXA, dual-energy X-ray absorptiometry.

OSENVELT is administered like Xgeva1,3

OSENVELT is available in single-dose vials designed for ease of use, precision dosing, and reduced medication errors

Celltrion offers comprehensive support for OSENVELT

We can help you empower your patients to navigate their treatment journeys confidently.

FIND RESOURCES
FIND RESOURCES

References: 1. OSENVELT Prescribing Information. Celltrion USA, Inc; 2024. 2. Reginster JY, Czerwinski E, Wilk K, et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a 
double-blind, randomized, active controlled, phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024;35(11):1919-1930. 3. Xgeva Prescribing Information. Amgen, Inc; 2020. 4. US Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed March 17, 2025. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf

IMPORTANT SAFETY INFORMATION

Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products.

Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly.

Hypersensitivity. Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT.

Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake.

Osteonecrosis of the Jaw (ONJ). ONJ can occur in patients on OSENVELT. A routine oral exam and appropriate preventive dentistry are recommended before starting and during treatment with OSENVELT. Good oral hygiene should be maintained. Avoid invasive dental procedures during treatment with OSENVELT. For invasive dental procedures, consider temporary discontinuation of OSENVELT. If ONJ develops, consult a dentist or oral surgeon. Extensive surgery may worsen ONJ, consider discontinuing OSENVELT based on a benefit-risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures. Atypical femoral fracture has been reported with denosumab products. During OSENVELT treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients with thigh or groin pain should be evaluated for an atypical femur fracture, including assessment for potential fractures in the contralateral limb. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, sometimes requiring hospitalization and complicated by acute renal injury, has occurred in denosumab-treated patients with giant cell tumor of bone and in those with growing skeletons, often within the first year after discontinuation. After treatment discontinuation, monitor for hypercalcemia symptoms, check serum calcium periodically, reassess calcium and vitamin D needs, and manage as appropriate.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. Evaluate the individual patient’s risk for vertebral fractures after OSENVELT discontinuation.

Embryo-Fetal Toxicity. Denosumab may cause fetal harm based on animal studies and its mechanism of action. Verify pregnancy status in females of reproductive potential before starting OSENVELT and advise them to use effective contraception during treatment and for 5 months after the last dose to prevent fetal harm.

Adverse Reactions:

  • Bone Metastasis from Solid Tumors: Most common adverse reactions (≥25%) were fatigue/asthenia, hypophosphatemia, and nausea.
  • Multiple Myeloma: Most common adverse reactions (≥10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
  • Giant Cell Tumor of Bone: Most common adverse reactions (≥10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
  • Hypercalcemia of Malignancy: Most common adverse reactions (>20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

Please see full Prescribing Information.

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.

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

Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products.

Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly.

Hypersensitivity. Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT.

Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake.

Osteonecrosis of the Jaw (ONJ). ONJ can occur in patients on OSENVELT. A routine oral exam and appropriate preventive dentistry are recommended before starting and during treatment with OSENVELT. Good oral hygiene should be maintained. Avoid invasive dental procedures during treatment with OSENVELT. For invasive dental procedures, consider temporary discontinuation of OSENVELT. If ONJ develops, consult a dentist or oral surgeon. Extensive surgery may worsen ONJ, consider discontinuing OSENVELT based on a benefit-risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures. Atypical femoral fracture has been reported with denosumab products. During OSENVELT treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients with thigh or groin pain should be evaluated for an atypical femur fracture, including assessment for potential fractures in the contralateral limb. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, sometimes requiring hospitalization and complicated by acute renal injury, has occurred in denosumab-treated patients with giant cell tumor of bone and in those with growing skeletons, often within the first year after discontinuation. After treatment discontinuation, monitor for hypercalcemia symptoms, check serum calcium periodically, reassess calcium and vitamin D needs, and manage as appropriate.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. Evaluate the individual patient’s risk for vertebral fractures after OSENVELT discontinuation.

Embryo-Fetal Toxicity. Denosumab may cause fetal harm based on animal studies and its mechanism of action. Verify pregnancy status in females of reproductive potential before starting OSENVELT and advise them to use effective contraception during treatment and for 5 months after the last dose to prevent fetal harm.

Adverse Reactions:

  • Bone Metastasis from Solid Tumors: Most common adverse reactions (≥25%) were fatigue/asthenia, hypophosphatemia, and nausea.
  • Multiple Myeloma: Most common adverse reactions (≥10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
  • Giant Cell Tumor of Bone: Most common adverse reactions (≥10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
  • Hypercalcemia of Malignancy: Most common adverse reactions (>20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

Please see full Prescribing Information.

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.