Sandoz biologics license application for denosumab accepted by FDA

Sandoz has received the Food and Drug Administration's acceptance for its Biologics License Application 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 that has spread to the bone, giant cell tumor of the bone and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. 

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“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 and head of North America.

“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 U.S., while also delivering savings for healthcare systems.”

In the United States 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.

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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.