Big Molecule Watch
January 19, 2023

Chinese Market Biosimilar Update

This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab).  BAT1806 is approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS), and is the first tocilizumab biosimilar approved by any regulatory agency.  BAT1806 is Bio-Thera’s third NMPA-approved biosimilar.

Last week, Luye Pharma Group announced that Boan Biotech and CP Pharmaceutical Qingdao entered into an agreement to commercialize BOYOUBEI, a denosumab biosimilar, in mainland China.   As we previously reported, BOYOUBEI is the first denosumab biosimilar approved for marketing by any regulatory agency, after approval by NMPA in November 2022.  BOYOUBEI is approved to treat osteoporosis in postmenopausal women at high risk of fracture.

To learn about more biosimilars approved by the NMPA, please check out Big Molecule Watch’s China site [中国获批的生物类似药 | Approved Biosimilars in China – 聚焦大分子 | 聚焦大分子 (].


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