CSPC Pharmaceutical Group has submitted for review its chemically synthesised semaglutide injection with China's National Medical Products Administration (NMPA), positioning it as a potential best-in-class biosimilar to Novo Nordisk's Ozempic. The candidate showed comparable bioactivity and weight-loss effects to recombinant DNA-produced semaglutide in preclinical studies, with lower impurity levels and improved storage stability at 2°C to 8°C. CSPC has conducted multiple clinical trials for type 2 diabetes (T2D) and obesity indications.

The filing enters a competitive landscape, with nine other Chinese biosimilars from firms including Jiuyuan Gene Engineering, Livzon Pharmaceutical and Qilu Pharmaceutical also under review. CSPC’s synthetic approach avoids host protein contaminants from fermentation, potentially offering manufacturing advantages. The move aligns with China's push to localise GLP-1 therapies amid surging demand for metabolic disease treatments.

PharmCube's NextBiopharm® database lists a total of 51 semaglutide biosimilars currently under development, including seven under review. Click here to request a free trial for NextBiopharm®.