Blog Big Molecule Watch November 14, 2022

China Approves World’s First Denosumab Biosimilar

Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures.  Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive approval for a PROLIA®/XGEVA®  (denosumab) biosimilar product.  Denosumab is a fully-human IgG2 monoclonal antibody that binds to RANKL and is used to treat osteoporosis including by reducing resorptive bone loss, increasing bone strength, and reducing fractures.  According to the press release, BOYOBEI® is also being developed for markets outside of China, including Europe and the United States, and will eventually seek marketing approval globally.

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