Mabwell Announces Approval of Denosumab Biosimilar MAILISHU in China

On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in postmenopausal women at high risk of fracture. MAILISHU was developed by Mabwell’s wholly owned subsidiary, T-Mab. Mabwell stated that MAILISHU is the world’s second approved biosimilar to denosumab, following the NMPA’s approval of Luye Pharma Group’s BOYOBEI (denosumab) in November 2022. In the United States, denosumab is marketed by Amgen under the trade names PROLIA and XGEVA.

We first reported on MAILISHU’s approval on Big Molecule Watch’s China blog. Stay up to date on biosimilar applications and approvals in China by following Big Molecule Watch’s biosimilar applications tracker and approved biosimilars tracker.