Eli Lilly's Insulin Glargine Injection (Basaglar®) Receives NMPA Approval in China

Humulin^®Is the world's first insulin biosimilar¹, which is currently the most widely used insulin biosimilar worldwide.², It has the same amino acid sequence and drug formulation as the original insulin glargine. Compared with traditional insulin, long-acting human insulin analogs (insulin glargine) have more advantages over treatment drugs such as intermediate-acting insulin in reducing the incidence of nocturnal hypoglycemia in patients and controlling fasting blood glucose.³

Humulin^®Strictly following the requirements of the "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)" issued by the Center for Drug Evaluation of the National Medical Products Administration in 2015, it was developed and approved for marketing. A Phase 1 study (ABEF study) conducted in healthy adults in China confirmed the safety of You Mi An.^®Highly similar to the original drug in terms of pharmacokinetics/pharmacodynamics (PK/PD) characteristics. Two Phase 3 studies conducted in Chinese adult patients with Type 1 and Type 2 diabetes (ABES study and ABET study) both confirmed the efficacy of YouMiAn.^®Similar efficacy and safety profiles to the originator drug. Both Phase 3 studies demonstrated non-inferiority at a 0.4% margin for the primary endpoint.^®Once-daily dosing (QD) is non-inferior to the original insulin glargine QD; the key secondary endpoint demonstrated that the original insulin glargine is non-inferior to You Mi An.^®; Therefore, Humulin^®Has equivalent efficacy to the original insulin glargine. You Mi An^®Can provide Chinese patients with type 1 and type 2 diabetes a once-daily, well-tolerated, and effective basal insulin option.