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FDA Approves 2 Biosimilars…in one — Jubbonti & Wyost

The FDA recently approved a ‘two-fer’…. yep, TWO identical biosimilars with the approval of Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) from Sandoz, Inc. They are the same formulations, and both received the coveted interchangeable designation. They are the first interchangeable biosimilars for RANKL inhibitors. Both therapies are available for subcutaneous administration. 

Jubbonti is indicated for the following (which are also currently approved for Prolia.)

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

Wyost is indicated for the following (which are also currently approved for Xgeva.)

  • 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.

CLICK HERE to access prescribing information for both therapies.

Sandoz has yet to confirm pricing. 

Similarly, distribution details for either/both therapies have not been disclosed.

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