USFDA accepts Biologics License Application for proposed biosimilar denosumab: Sandoz

“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.”

In the US alone, more than 10 million adults over age 50 are estimated to have osteoporosis, of whom more than 80% are women. It is predicted that one in two of these women and one in four men will have an osteoporosis-related fracture in their lifetimes. Osteoporosis-related fractures may lead to diminished quality of life, disability, and even death.

The 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 a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue). By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.

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