Home Medizin FDA genehmigt erstes Denosumab-Biosimilar

FDA genehmigt erstes Denosumab-Biosimilar

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved the first biosimilar to Denosumab, Denosumab-bddz (Wyost/Jubbonti).

The biosimilar has also been granted interchangeability status, allowing pharmacists to substitute the reference product with the biosimilar without involving the prescribing physician (in accordance with state law). Sandoz announced the approval on March 5, 2024. The lower dosage of Denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February.

The FDA approval „is based on robust clinical studies and is accompanied by labeling with safety warnings,“ according to the press release. Like the reference products Prolia and Xgeva, Denosumab-bddz is approved for two indications in separate dosages.

Wyost (120 mg/1.7 ml injection) is approved for:

  • Preventing skeletal-related events in patients with multiple myeloma and in patients with bone metastases due to solid tumors
  • Treating adults and skeletally mature adolescents with giant cell tumors of bone that are unresectable or where surgical resection is likely to result in severe morbidity
  • Treating hypercalcemia in cancer patients who do not respond to bisphosphonate therapy

Jubbonti (60 mg/1 ml injection) is approved for:

  • Treating postmenopausal women with osteoporosis who are at high risk of fracture
  • Increasing bone mass in men with osteoporosis who are at high risk of fracture
  • Treating glucocorticoid-induced osteoporosis in men and women at high risk of fracture
  • Increasing bone mass in men at high risk of fracture receiving androgen deprivation therapy for non-metastatic prostate cancer
  • Increasing bone mass in women at high risk of fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Both dosages are contraindicated in hypocalcemia and in patients with known clinically significant hypersensitivity to Denosumab products. Exposure to Denosumab products during pregnancy may result in fetal harm. Women of childbearing age should be advised to use effective contraception during therapy and for at least 5 months after the last dose of Denosumab-bddz.

Sandoz did not provide details on the US market launch and cited „ongoing patent disputes surrounding these products.“

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