Novartis' biosimilar of Amgen's bone disorder drugs Prolia, Xgeva gets FDA review
Michael Derrer Fuchs


Novartis' (NYSE:NVS) unit Sandoz said on Monday that the U.S. Food and Drug Administration (FDA) accepted its biologics license application (BLA) for proposed biosimilar denosumab.
The BLA includes all indications covered by the reference medicines, Amgen's (NASDAQ:AMGN) Prolia (denosumab) and Xgeva (denosumab) to treat several 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 to treat hypercalcemia of malignancy refractory to bisphosphonate therapy, the company noted.

The Swiss pharma giant noted that the submission was backed by data from a phase 1/3 study, dubbed ROSALIA.
"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 and head of North America.