Novartis Announces Biosimilar to Amgen's Prolia Demonstrates Equivalent Efficacy and Safety Profile

Gelonghui, September 20th ┃ Novartis (NVS.US) stated that its biosimilar to Amgen's (AMGN.US) osteoporosis drug Prolia (denosumab) matches Prolia in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity.

Prolia is used to treat a variety of conditions, including osteoporosis in postmenopausal women, men with an increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related events in cancers that have spread to the bone, and giant cell tumor of bone. Sandoz, a Novartis subsidiary, noted that approximately 500 million men and women worldwide may be affected by osteoporosis, causing about 89 million fractures annually.