Sandoz, a Novartis (NVS) division, announced the FDA has accepted its Biologics License Application for proposed biosimilar denosumab. The BLA includes an analytical and clinical data package, including data from the Phase I/III ROSALIA study.
"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 Inc. and Head of North America.
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