For US healthcare professionals only

Why prescribe STOBOCLO?

STOBOCLO is an FDA-approved biosimilar of Prolia®, with similar indications, dosing and administration, and MOA.1*

Comparable efficacy and safety to Prolia—shown to 78 weeks2

STOBOCLO offers similar indications, dosage form, and strength as Prolia so you can integrate STOBOCLO 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.

STOBOCLO strengthened bones over 78 weeks–similar to Prolia2

In a switch trial of postmenopausal women with osteoporosis, all treatment groups demonstrated significant change over baseline at the end of the trial2

Explore The Results

Mean percent change from baseline in lumbar spine BMD2

  • Percent change from baseline in lumbar spine BMD by DXA at week 52 was assessed as the primary endpoint2
  • Based partly on the findings from this study, STOBOCLO has been approved as biosimilar to Prolia across all Prolia indications, including treatment of postmenopausal women with osteoporosis at high risk for fracture; increasing bone mass in men with osteoporosis at high risk for fracture or men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; and increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to another, including clinical trials, blood and immune system evaluations, and chemical analyses. STOBOCLO passed those tests and is officially biosimilar to Prolia1-4
Explore The Results

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

STOBOCLO is dosed and administered like Prolia1,3

STOBOCLO is available in a user-friendly, prefilled syringe designed for ease of use, precision dosing, and reduced medication errors.1

EXPLORE DOSING AND ADMINISTRATION

Celltrion offers comprehensive support for STOBOCLO

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

SEE RESOURCES
SEE RESOURCES

References: 1. STOBOCLO 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. Prolia Prescribing Information. Amgen, Inc.; 2024. 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

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE

Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following the administration of denosumab products. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.

Prior to initiating STOBOCLO in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with STOBOCLO in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD

Contraindications:

  • Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating therapy.
  • Pregnancy: Denosumab products may cause fetal harm when administered to a pregnant woman.
  • Hypersensitivity: Known hypersensitivity to denosumab products.

Severe Hypocalcemia and Mineral Metabolism Changes. Severe hypocalcemia can occur. Ensure adequate calcium and vitamin D supplementation.

Drug Products with Same Active Ingredient. Patients receiving STOBOCLO 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 STOBOCLO.

Osteonecrosis of the Jaw (ONJ). ONJ can occur in patients on STOBOCLO, particularly after tooth extraction and/or local infection with delayed healing. A routine oral exam is recommended before starting STOBOCLO, with a dental evaluation and preventive care for high-risk patients. Good oral hygiene should be maintained, and ONJ-risk drugs may heighten ONJ likelihood, especially with extended STOBOCLO exposure. For invasive dental procedures, individualize treatment based on clinical judgment. If ONJ develops, consult a dentist or oral surgeon. Extensive surgery may worsen ONJ, consider discontinuing STOBOCLO based on a benefit-risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures. Atypical low energy or low trauma fractures of the shaft have been reported in patients receiving denosumab products. During STOBOCLO 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 STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis.

Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment. Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab discontinuation. Evaluate an individual's benefit-risk before initiating treatment with STOBOCLO. If STOBOCLO treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.

Serious Infections. In a trial of women with postmenopausal osteoporosis, serious infections were more frequent with denosumab than placebo, including skin, abdominal, urinary, ear infections, and endocarditis. Overall infection rates were similar between groups. Advise patients to seek medical attention for severe infection symptoms like cellulitis. Those on immunosuppressants or with weakened immune systems may face higher risks. Assess the benefit-risk profile before starting STOBOCLO, and reconsider its use if serious infections develop.

Dermatologic Adverse Reactions. Epidermal and dermal adverse events such as dermatitis, eczema, and rashes have been reported in patients treated with denosumab. Consider discontinuing STOBOCLO if severe symptoms develop.

Musculoskeletal Pain. In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking denosumab products. Consider discontinuing use if severe symptoms develop.

Suppression of Bone Turnover. In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodeling, with unknown long-term effects that may lead to osteonecrosis of the jaw, atypical fractures, or delayed fracture healing; patients should be monitored for these outcomes.

Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta. STOBOCLO is not indicated for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products. Some cases required hospitalization.

Adverse Reactions:

  • Postmenopausal osteoporosis: Most common adverse reactions (> 5%) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
  • Male osteoporosis: Most common adverse reactions (> 5%) were: back pain, arthralgia, and nasopharyngitis.
  • Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3%) were: back pain, hypertension, bronchitis, and headache.
  • Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥10%) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

STOBOCLO (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:

  • of postmenopausal women with osteoporosis at high risk for fracture
  • to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer

INDICATIONS

STOBOCLO (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:

  • of postmenopausal women with osteoporosis at high risk for fracture
  • to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer;

IMPORTANT SAFETY INFORMATION

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE

Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following the administration of denosumab products. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.

Prior to initiating STOBOCLO in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with STOBOCLO in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD

Contraindications:

  • Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating therapy.
  • Pregnancy: Denosumab products may cause fetal harm when administered to a pregnant woman.
  • Hypersensitivity: Known hypersensitivity to denosumab products.

Severe Hypocalcemia and Mineral Metabolism Changes. Severe hypocalcemia can occur. Ensure adequate calcium and vitamin D supplementation.

Drug Products with Same Active Ingredient. Patients receiving STOBOCLO 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 STOBOCLO.

Osteonecrosis of the Jaw (ONJ). ONJ can occur in patients on STOBOCLO, particularly after tooth extraction and/or local infection with delayed healing. A routine oral exam is recommended before starting STOBOCLO, with a dental evaluation and preventive care for high-risk patients. Good oral hygiene should be maintained, and ONJ-risk drugs may heighten ONJ likelihood, especially with extended STOBOCLO exposure. For invasive dental procedures, individualize treatment based on clinical judgment. If ONJ develops, consult a dentist or oral surgeon. Extensive surgery may worsen ONJ, consider discontinuing STOBOCLO based on a benefit-risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures. Atypical low energy or low trauma fractures of the shaft have been reported in patients receiving denosumab products. During STOBOCLO 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 STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis.

Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment. Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab discontinuation. Evaluate an individual's benefit-risk before initiating treatment with STOBOCLO. If STOBOCLO treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.

Serious Infections. In a trial of women with postmenopausal osteoporosis, serious infections were more frequent with denosumab than placebo, including skin, abdominal, urinary, ear infections, and endocarditis. Overall infection rates were similar between groups. Advise patients to seek medical attention for severe infection symptoms like cellulitis. Those on immunosuppressants or with weakened immune systems may face higher risks. Assess the benefit-risk profile before starting STOBOCLO, and reconsider its use if serious infections develop.

Dermatologic Adverse Reactions. Epidermal and dermal adverse events such as dermatitis, eczema, and rashes have been reported in patients treated with denosumab. Consider discontinuing STOBOCLO if severe symptoms develop.

Musculoskeletal Pain. In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking denosumab products. Consider discontinuing use if severe symptoms develop.

Suppression of Bone Turnover. In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodeling, with unknown long-term effects that may lead to osteonecrosis of the jaw, atypical fractures, or delayed fracture healing; patients should be monitored for these outcomes.

Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta. STOBOCLO is not indicated for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products. Some cases required hospitalization.

Adverse Reactions:

  • Postmenopausal osteoporosis: Most common adverse reactions (> 5%) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
  • Male osteoporosis: Most common adverse reactions (> 5%) were: back pain, arthralgia, and nasopharyngitis.
  • Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3%) were: back pain, hypertension, bronchitis, and headache.
  • Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥10%) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

STOBOCLO (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:

  • of postmenopausal women with osteoporosis at high risk for fracture
  • to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer