Chicago — Meitheal Pharmaceuticals said the U.S. Food and Drug Administration has approved Garzulys, a rapid-acting insulin biosimilar intended to improve blood sugar control in adults and children with diabetes.
Garzulys, or insulin aspart-fsan, is biosimilar to NovoLog and is approved for both subcutaneous and intravenous administration.
Emerge Bioscience holds the approved Biologics License Application for the product. Meitheal serves as Garzulys’ U.S. regulatory agent and holds exclusive commercialization rights in the United States under a licensing agreement with Emerge.
The approval marks Meitheal’s continued expansion beyond generic injectable medicines into biologics and branded products.
“The 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,” Meitheal Chief Executive Officer Tom Shea said.
“We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure and strategic partnerships needed to expand patient access to high-quality biologic treatment options,” Shea added.
Garzulys was developed through a collaboration involving Tonghua Dongbao Pharmaceutical, Nanjing King-Friend Biochemical Pharmaceutical, Xentria, Meitheal and Emerge.
Tonghua Dongbao led development of the drug substance, while Nanjing King-Friend was responsible for development of the finished drug product. Xentria led the clinical development program, and Meitheal managed the U.S. regulatory work supporting the FDA submission.
Emerge is responsible for key supply-chain activities associated with the product.
The collaboration, which began in 2023, also includes two additional insulin biosimilar candidates that remain in development. Meitheal holds exclusive U.S. commercialization rights to all three products under its agreement with Emerge.
Garzulys expands Meitheal’s presence in diabetes care and supports its strategy of developing a broader portfolio of biologic and branded medicines.
Founded in 2017, Meitheal has built a U.S. portfolio of more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility.
Garzulys is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin aspart-fsan or any of the product’s ingredients.
