Meitheal Pharmaceuticals has gained FDA approval for GARZULYS, a rapid-acting insulin biosimilar, intensifying competition in a market historically dominated by originator products and few biosimilar entries.
Meitheal Pharmaceuticals said on July 30, 2026 that the U.S. Food and Drug Administration has approved GARZULYS, a rapid-acting insulin biosimilar to Novo Nordisk’s Novolog, for use in adults and children with diabetes. The product is cleared for both subcutaneous and intravenous administration, giving clinicians another treatment option in a category that has been dominated by the originator product and only a small number of biosimilar entrants.
According to the FDA’s biosimilar product information page, GARZULYS is now listed among approved biosimilars, confirming the agency’s action in July 2026. The FDA had already set an important precedent in February 2025 when it approved Merilog, describing it as the first rapid-acting insulin biosimilar for diabetes treatment.
Meitheal said Emerge Bioscience is the biologics licence applicant for GARZULYS, while Meitheal serves as the U.S. regulatory agent and holds exclusive commercial rights in the country under a licensing agreement. The company also said Tonghua Dongbao Pharmaceutical handled drug substance development and that Xentria led the clinical programme.
The approval adds momentum to a pipeline Meitheal assembled under a 2023 licensing deal for three insulin biosimilars: insulin aspart, insulin lispro and insulin glargine. Meitheal’s own product information suggests the glargine candidate has completed phase 3 testing, while the lispro version is still in phase 1, indicating the company is trying to build a broader diabetes franchise rather than rely on a single launch.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
