The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis and to prevent bone problems in cancer. The approval puts up a strong challenge to Amgen Inc.’s Prolia, the first biologic for osteoporosis, and Xgeva, for bone cancer.
The skeleton undergoes continuous remodeling throughout life in response to diverse environmental stimuli. Osteoclasts, which are specialized cells on the bone surface, break down old bone tissue (in a process known as bone resorption) and build it back up. Dysregulation of osteoclast formation and function can lead to bone fragility, including osteoporosis, which is estimated to affect over 10 million people globally.