Is denosumab (Prolia) the same as denosumab (Prolia)?

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From the Guidelines

No, Jubbonti is not the same as Prolia, as Jubbonti is a brand name for romosozumab, while Prolia is a brand name for denosumab, which are different medications used to treat osteoporosis with distinct mechanisms of action. The provided evidence does not directly compare Jubbonti and Prolia, but it discusses the use of denosumab (Prolia) in the context of preventing skeletal-related events (SREs) in patients with cancer and bone metastases 1. Denosumab is a monoclonal antibody that targets RANK ligand to decrease bone resorption, and it is usually administered as an injection once every 4 weeks for patients with castration-resistant prostate cancer (CRPC) and bone metastases. On the other hand, romosozumab (Jubbonti) is a monoclonal antibody that blocks sclerostin, increasing bone formation while decreasing bone resorption, but its use is not mentioned in the provided evidence.

Key Differences

  • Mechanism of action: Romosozumab (Jubbonti) blocks sclerostin, while denosumab (Prolia) targets RANK ligand.
  • Indications: Denosumab (Prolia) is used to prevent SREs in patients with CRPC and bone metastases, as well as to treat osteoporosis in men and women.
  • Administration: Denosumab (Prolia) is administered as an injection once every 4 weeks for patients with CRPC and bone metastases, while romosozumab (Jubbonti) is typically given as a monthly injection for 12 months.
  • Side effects: Both medications have different side effect profiles, with denosumab (Prolia) associated with hypocalcemia, arthralgias, and osteonecrosis of the jaw, while romosozumab (Jubbonti) has its own set of potential side effects.

Clinical Considerations

When deciding between Jubbonti and Prolia, clinicians should consider the patient's specific needs and medical history, including the presence of bone metastases, osteoporosis, and renal function. Denosumab (Prolia) may be preferred in patients with CRPC and bone metastases, while romosozumab (Jubbonti) may be considered for patients with osteoporosis who require a different mechanism of action. However, the provided evidence does not support the use of Jubbonti in the context of cancer and bone metastases, and therefore, denosumab (Prolia) is the preferred option in this setting, as supported by the study published in the Journal of the National Comprehensive Cancer Network 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Comparison of Jubbonti and Prolia

  • Jubbonti is a biosimilar to reference denosumab (Prolia) 2
  • Both Jubbonti and Prolia are fully human monoclonal antibodies against the receptor activator of the nuclear factor kappaB ligand 3, 2
  • They have the same mechanism of action, preventing bone resorption and loss of bone density/architecture in conditions characterized by excessive bone loss such as osteoporosis 2

Efficacy and Safety

  • Jubbonti has been shown to be similar in efficacy to Prolia in postmenopausal women with osteoporosis 2
  • Both Jubbonti and Prolia have been associated with a range of side effects, including infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw, and atypical femur fractures 3, 4
  • Discontinuation of denosumab (Prolia) has been associated with a rapid rebound in bone turnover and increased fracture risk 4, 5

Regulatory Approval

  • Jubbonti (SDZ-deno) has been approved by the US FDA, EMA, and Health Canada for all indications of reference denosumab (Prolia) 2
  • The approval of Jubbonti was based on a totality of evidence that established its biosimilarity to Prolia 2

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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