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Denosumab Biosimilars Receive FDA Approval

May 9, 2024

June 2024

Wyost, a denosumab biosimilar developed by Sandoz, received U.S. Food and Drug Administration (FDA) approval for all indications of denosumab.

Approval of the biosimilar, which is a human monoclonal antibody injection, was granted based on the results of positive clinical trial data.

Indications for the medication include prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone in adults and skeletally mature adolescents, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Common adverse reactions associated with the treatment include diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.

Sandoz also received approval for another denosumab biosimilar, Jubbonti.

"Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients,” said Keren Haruvi, president of Sandoz North America.

Source: Sandoz, March 5, 2024.

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