FDA Accepts Biologics License Application for Proposed Denosumab Biosimilar

Drug Topics JournalDrug Topics March 2023
Volume 167
Issue 03

The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women

Sandoz has announced that the FDA has accepted the biologics license application (BLA) for a proposed biosimilar of denosumab (Prolia; Xgeva) for the treatment of osteoporosis in post-menopausal women (and in men
at increased risk of fractures), skeletal-related complications in cancer that has spread to the bone, treatment-induced bone loss, giant cell tumor of the bone, and hypercalcemia of malignancy refractory to bisphosphonate therapy, according to a company press release.1

Denosumab is a human monoclonal antibody, created to bind to and inhibit the RANKL protein that activates osteoclasts. By decreasing their activity, the agent curtails bone loss and lowers the risk of fractures and other major bone conditions, per Sandoz.

“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 [older than] 50 [years]
are at risk of,” said Keren Haruvi, president of Sandoz Inc. 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 US, while also delivering savings for health care systems,” Haruvi added.

The BLA acceptance was based on positive clinical data from the ROSALIA study (NCT03974100), which confirmed that the proposed biosimilar matches the reference medication in efficacy, safety immunogenicity, pharmacokinetics, and pharmacodynamics in women with postmenopausal osteoporosis.


1. Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA. Novartis. February 6, 2023. Accessed February 6, 2023. https://www.novartis.com/news/media- releases/sandoz-biologics-license-application-proposed-biosimilar- denosumab-accepted-us-fda

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