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The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
Novartis announced that FDA has accepted Sandoz’s biologics license application (BLA) for the proposed biosimilar denosumab. The application features all indications covered by the reference medicines Prolia (denosumab) and Xgeva (denosumab) for treating multiple conditions, such as osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” said Keren Haruvi, president of Sandoz Inc. and Head of North America, in a press release. “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 healthcare systems.”
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. According to the company, the results confirmed that the proposed biosimilar denosumab matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity in women with postmenopausal osteoporosis and contributes to the demonstration of similarity, which is the basis for use in all indications.