Meitheal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog® (insulin aspart). Indicated to improve glycemic control in both adult and pediatric patients with diabetes mellitus, Garzulys™ is approved for both subcutaneous and intravenous administration.
Emerge Bioscience Pte. Ltd. (“Emerge”) holds the approved Biologics License Application (BLA) and handles key supply-chain activities, while Meitheal serves as the U.S. Regulatory Agent and holds exclusive U.S. commercialization rights. The product was developed through a strategic global collaboration between Tonghua Dongbao Pharmaceutical Co., Ltd. (drug substance development), Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (drug product development), Xentria, Inc. (clinical development lead), and Meitheal (U.S. regulatory lead).
The approval represents a major milestone in Meitheal’s strategy to expand beyond generic injectables into complex biologics and branded products. Part of a multi-product insulin agreement initiated in 2023, Garzulys™ further strengthens Meitheal’s U.S. portfolio, which includes over 80 FDA-approved products across key therapeutic areas.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
