The US Food and Drug Administration (FDA) has approved Garzulys (insulin aspart-fsan) injection, a biosimilar to NovoLog (insulin aspart), for the treatment of diabetes mellitus.
The approved Biologics License Application (BLA) is held by Singapore-based Emerge Bioscience, while Meitheal Pharmaceuticals serves as the product’s US Regulatory Agent and holds exclusive US commercialization rights under a licensing agreement with Emerge.
Garzulys is a rapid-acting human insulin analog indicated to improve glycaemic control in both adults and paediatric patients with diabetes mellitus. The product is approved for both subcutaneous and intravenous administration.
The biosimilar was developed through a global collaboration between Chinese pharmaceutical company Tonghua Dongbao and companies affiliated with Meitheal. Tonghua Dongbao led the drug substance development, Nanjing King-Friend Biochemical Pharmaceutical (NKF) was responsible for drug product development, Xentria directed the clinical development programme and Meitheal led the US regulatory work that supported FDA approval. Emerge, as the BLA holder, oversees key supply chain activities for the product.
The partnership between Tonghua Dongbao and NKF, launched in 2023, includes Garzulys as well as two additional insulin biosimilar candidates currently under development. Through its exclusive agreement with Emerge, Meitheal also holds US commercialization rights for these pipeline candidates.
“The US FDA approval of Garzulys represents an important milestone in Meitheal’s continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products,” said Tom Shea, CEO of Meitheal.
According to Meitheal, the approval strengthens its presence in the diabetes care market and supports its strategy of expanding its biologics and branded medicines portfolio.
