Novartis’ Sandoz BLA for proposed biosimilar denosumab accepted by FDA

Sandoz announced that the U.S. Food and Drug Administration has accepted its Biologics License Application, or BLA, for proposed biosimilar denosumab. "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. 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," said Keren Haruvi, President, Sandoz Inc. and Head of North America.