Denosumab Biosimilar for Osteoporosis, Other Conditions Under FDA Review

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for a proposed biosimilar to denosumab.

Denosumab is a RANK ligand inhibitor that is approved under the brand name Prolia for the treatment of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Denosumab is also indicated under the brand name Xgeva for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity; and for treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

According to Sandoz, the BLA is supported by a comprehensive data package that includes data from the phase 1/3 ROSALIA study ( Identifier: NCT03974100). In this study, 527 postmenopausal women with osteoporosis were randomly assigned to receive either biosimilar denosumab or the reference product for up to 78 weeks of treatment. Findings demonstrated similarity between the 2 products with regard to pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity.

“We are proud to be among the first to submit a BLA for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for health care systems,” said Keren Haruvi, President, Sandoz Inc. and Head of North America.


Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA. News release. February 6, 2023.

This article originally appeared on MPR

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