US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children and adolescents aged 6 years and above with type 1 diabetes.
YouBiAn: A Milestone in Insulin Biosimilars
YouBiAn, recognized as the world’s first insulin biosimilar, boasts the same amino acid sequence and drug formulation as Sanofi’s originator insulin glargine Lantus. This long-acting insulin glargine analogue offers significant advantages over natural insulin, particularly in reducing the incidence of nocturnal hypoglycemia and controlling fasting blood sugar levels in patients.
Regulatory Compliance and Clinical Evidence
Developed in accordance with the “Guiding Principles for the Development and Evaluation of Biosimilars (Trial)” issued by the Center for Drug Evaluation (CDE) in 2015, YouBiAn has demonstrated equivalent efficacy and safety profiles compared to the originator in Phase III ABES and ABET studies involving type 1 and type 2 diabetes patients in China.
Market Competition and Procurement
With this approval, Eli Lilly joins other approved biosimilars from Gan & Lee Pharma, United Laboratories, THDB, and HEC in the Chinese market. Insulin glargine was included in a special volume-based procurement (VBP) round held in November 2021, where Sanofi’s products secured 85% of the allocation following a 47% price reduction, indicating the competitive landscape and the impact of biosimilars on pricing and accessibility.-Fineline Info & Tech
