FDA accepts BLA for Sandoz proposed denosumab biosimilar


The US Food and Drug Administration has accepted the Biologics License Application (BLA) for a proposed biosimilar of denosumab (Prolia and Xgeva; Amgen) for treatment of various conditions.

Sandoz has announced that the US Food and Drug Administration has accepted the Biologics License Application (BLA) for a proposed biosimilar of denosumab (Prolia and Xgeva; Amgen) for the treatment of various conditions.

Some of these conditions include osteoporosis in postmenopausal women and in men at increased risk of fractures, prevention of skeletal-related complications in cancer that has spread to the bone, treatment-induced bone loss, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy, according to a company press release.

Denosumab is a human monoclonal antibody, created to bind to the RANKL protein, which is an activator of osteoclasts. The medicine decreases the activity of osteoclasts by inhibiting the RANKL protein, leading to a decrease in bone loss and the probability of fractures and other 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 over 50 are at risk of,” said Keren Haruvi, president of Sandoz Inc. and head of North America.

She added, “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.”

The BLA acceptance was based on positive clinical data from the ROSALIA study. Results from the study confirm the proposed biosimilar denosumab matches the reference medication in efficacy, safety immunogenicity, pharmacokinetics, and pharmacodynamics in women with postmenopausal osteoporosis.


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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