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Denosumab, sold under the brand names Prolia among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. [11] [12] The most common side effects are joint and muscle pain in the arms or legs. [13]
Denosumab is an FDA-approved fully human monoclonal antibody to RANKL and during pre-clinical trials was first used to treat postmenopausal patients suffering with osteoporosis (PMO). [ 21 ] [ 22 ] In denosumab's third stage of the FDA's clinical trial, it was shown to: (1) decrease bone turnover, (2) reduce fractures in the PMO population, and ...
Sandoz said in a statement that the agreement clears the way for the launch of denosumab biosimilars Jubbonti and Wyost on May 31, 2025, or earlier under certain circumstances.
Therapeutic, diagnostic and preventive monoclonal antibodies are clones of a single parent cell. When used as drugs, the International Nonproprietary Names (INNs) end in -mab.
The Food and Drug Administration has approved Amgen's (AMGN) osteoporosis drug denosumab for use by cancer patients with solid tumors whose disease has metastasized to their bones. The indication ...
Prolia, approved in 2010 to treat bone loss in postmenopausal women and later approved to treat men and women at high risk of fracture, brought in total third-quarter sales of $986 million.