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On July 30, 2026, Meitheal Pharmaceuticals, Inc. (“Meitheal”) announced that the U.S. Food and Drug Administration (“FDA”) has approved GARZULYS™ (insulin apsart-fsan) injection. GARZULYS™, a biosimilar to Novo Nordisk’s NOVOLOG® (insulin aspart), is a rapid-acting insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus and is approved for both subcutaneous and intravenous administration.
GARZULYS™ is the third insulin biosimilar approved by FDA, following Sanofi-Aventis’s MERILOG™, approved in February 2025, and Biocon Biologics’ interchangeable biosimilar KIRSTY™ (insulin aspart-xjhz), approved in July 2015.
Emerge Bioscience Pte. Ltd. (“Emerge”) is the BLA-holder for GARZULYS™, and Meitheal serves as the product’s U.S. regulatory agent and holds exclusive U.S. commercialization rights under a license agreement with Emerge. According to Mitheal, Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao”) was responsible for drug substance development and clinical development was led by Xentria, Inc.
As we previously reported, in 2023 Meitheal entered into an exclusive licensing deal with Tonghua Dongboa to market three insulin biosimilars–insulin aspart, insulin lispro, and insulin glargine–in the United States. Currently, Meitheal’s pipeline indicates that an insulin glargine product has completed Phase 3, while an insulin lispro product is in Phase 1.
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