On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™ (insulin aspart-fsan) injection, biosimilar to Novo Nordisk’s NovoLog®. Garzulys™ is indicated to improve glycaemic control in adult and paediatric patients with diabetes mellitus and is approved for both intravenous and subcutaneous administration.
Garzulys™ was developed by China-based Tonghua Dongbaou Pharmaceutical and companies affiliated with Meitheal. The Biologics License Application (BLA) is held by Emerge Biosciences. Meitheal is the US regulatory agent with exclusive US commercialisation rights for Garzulys™ under a 2023 licence agreement with Emerge.
According to Meitheal, the FDA approval of Garzulys™ advances the company’s strategy to expand its established generic injectable business and build a broader portfolio of biologics and branded products. Meitheal is also commercialising Yusimry™, biosimilar to AbbVie’s Humira® (adalimumab) in the US after the product was divested from Coherus BioSciences to Hong Kong Friend, Meitheal’s parent company, in June 2024. A high concentration formulation of Yusimry™ is in development. Meitheal is also partnering with Boan Biotech on denosumab biosimilars, for which a regulatory submission has been lodged.
Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were the first US approved biosimilars to NovoLog® in February 2025. In July 2025, Biocon Biologics announced that the FDA approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable insulin aspart biosimilar.