Biosimilar medicine approvals


United States

The US Food and Drug Administration has approved two biosimilar drugs for the treatment of bone-related disorders – the first follow-on products for medicines developed by Amgen Inc. The new biosimilars, Wyost and Jubbonti, have been produced by Sandoz Group AG, a recent spin-out of Novartis. The active ingredient in both medicines, denosumab, is a human monoclonal antibody that binds to the RANKL protein, an activator of osteoclasts. Osteoclasts are cells that are involved in breaking down bone tissue.