Mabwell Approved to Launch Biosimilar to Amgen's Osteoporosis Therapy in China

Shanghai Mabwell was approved to launch a denosumab biosimilar in China for osteoporosis in postmenopausal women at high risk of fracture. Mailishu, which was developed by Mabwell’s subsidiary T-mab, was shown to reduce the risk of vertebral, non-vertebral and hip fractures. Denosumab is a humanized mAb that inhibits the activator of nuclear factor kappa-B ligand (RANKL) to prevent development of osteoclasts, the cells that break down bone. The originator drug, Amgen’s Prolia/Xgeva was approved in the US in 2010, recording $5.6 billion in global revenues last year. More details....

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