On 27 May 2024, Boan Biotech announced that its Boluojia® (BA11021, denosumab injection, 120mg) received marketing approval from China’s National Medical Products Administration (NMPA) as biosimilar to Amgen’s Xgeva®. Boluojia® is indicated for the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Boan Biotech reports that it intends to expand the approved indications for Boluojia® to include bone metastases from solid tumours and multiple myeloma.
Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia® (denosumab), was approved by China’s NMPA in November 2022 for postmenopausal women with osteoporosis at high risk of fractures.
In January 2024, Boan Biotech completed enrolment for its international, multi-centre, phase 3 studies of Boluojia® and Boyoubei®, which are being conducted simultaneously in Europe, the US and Japan.