Sandoz reports that the US Food and Drug Administration (FDA) has accepted its Biologics License 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 that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
A human monoclonal antibody, Denosumab is 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.
“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, Sandoz, and head of North America.
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.
Sandoz said its BLA application includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
Results, it continued, 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.
Sandoz is focused on the development of biosimilars for immunology, oncology, supportive care, and endocrinology. Its portfolio includes eight marketed biosimilars and a further 15-plus in various stages of development.