Pharma Focus Asia

Sandoz Biologics Licence Application Accepted by US FDA for Biosimilar Denosumab

Monday, February 06, 2023

Sandoz announced that the US Food and Drug Administration (FDA) has accepted its Biologics Licence Application (BLA) for proposed biosimilar denosumab.

The application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer which can spread to the bone, giant cell tumour of the bone, and treatment of hypercalcaemia of malignancy refractory to bisphosphonate therapy.

The first to submit a BLA for a denosumab biosimilar, if approved, it will increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, also delivering savings for healthcare systems.

The Biologics Licence Application (BLA) includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. 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 demonstration of similarity, which is the basis for use in all indications.

Denosumab is indicated for treating variety of conditions including osteoporosis in postmenopausal women.

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