Romosozumab (SOST) – Research Grade Biosimilar

Background:

Romosozumab is a humanized monoclonal antibody indicated for the treatment of osteoperosis in postmenopausal women at high risk of fracture and patients who have failed in other treatments or are intolerant to other osteoperosis therapies9. Romosozumab prevents bone resorption and induces the formation of bone though it is associated with an increased risk of cardiac death, heart attack, and stroke in one study7,8. In a comparison study of post menopausal women with osteoporosis and a past fracture, romosozumab for 12 months followed by alendronic acid for 12 months was superior to alendronic acid alone for 24 months3. Romosozumab also demonstrates a faster and larger increase in bone density than teriparatide4. Romosozumab is marketed in the United States by Amgen under the brand name Evinity7. Romosozumab was granted FDA approval on April 9,2019.