Boan Biotech has received approval from China's National Medical Products Administration for its dulaglutide biosimilar BA5101, marking the world’s first biosimilar version of Eli Lilly's blockbuster GLP-1 receptor agonist Trulicity. The weekly injectable demonstrated equivalent efficacy to the originator in Phase III trials, reducing glycated haemoglobin by 1.44% versus 1.41% at week 12. BA5101 showed comparable pharmacokinetics and safety in Phase I studies, with Boan overcoming complex manufacturing challenges in oxidation and charge heterogeneity.

The approval positions Boan ahead of six global competitors in the dulaglutide biosimilar race, including Lepu Medical and SL Pharma. Dulaglutide generated USD 5.3 billion in 2024 sales for Lilly, with advantages in glycaemic control, weight loss and cardiovascular protection. Boan's biosimilar could significantly reduce treatment costs for China's 140 million diabetes patients while maintaining the originator's once-weekly dosing convenience.

PharmCube's NextBiopharm® database lists six active clinical-stage programs developing dulaglutide biosimilars, mainly from Chinese companies. Click here to request a free trial for NextBiopharm®.