Boan Biotech announced that it has completed enrolment for the international multi-centre comparative clinical phase III study of BA6101 and BA11021, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively. The studies are being conducted simultaneously in Europe, the United States, and Japan.
Boan commenced the trials in May 2023. BA6101 (Boyoubei®) was approved for marketing in China in November 2022, as the first approved Prolia® biosimilar in the world, and China’s NMPA has accepted Boan’s BLA for approval as an Xgeva® biosimilar.