Amgen (AMGN) and Union Chimique Belge send Romosozumab Biologics License Application to FDA
In a recent press release, Amgen (NASDAQ: AMGN) and Union Chimique Belge (UCB) disclosed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Romosozumab. Romosozumab is a monoclonal anti-sclerostin antibody for the treatment of osteoporosis in postmenopausal women, a group at increased risk of fracture. A BLA is similar to a New Drug Application (NDA). However, since Romosozumab is an antibody, it is classified as a biologic rather than a drug. Monoclonal antibodies are those made by identical immune cells that are all clones of a unique parent cell. Announcing the application…