Meitheal's Garzulys gains FDA approval as new competitor in rapidly expanding insulin biosimilar market

Meitheal Pharmaceuticals has received FDA approval for Garzulys, a biosimilar of Novo Nordisk’s NovoLog, marking a significant step in the increasing competition in rapid-acting insulin options in the US market.

Meitheal Pharmaceuticals has won United States approval for Garzulys, a biosimilar version of Novo Nordisk’s NovoLog, adding a further rapid-acting insulin option to a market that has only recently begun to open up to such products. The Chicago-based company said the Food and Drug Administration cleared the injection on 30 July, with the treatment intended to improve glycaemic control in adults and children with diabetes and authorised for both intravenous and subcutaneous use.

The approval is notable because it comes after a series of firsts in the insulin-aspart category. Sanofi’s Merilog and Merilog SoloStar were the first rapid-acting insulin biosimilars approved in the US in February 2025, according to the company’s announcement and subsequent reporting by JAMA Network. In July 2025, the FDA also approved Biocon Biologics’ Kirsty as the first interchangeable biosimilar to NovoLog, a designation that signals the products are expected to deliver no clinically meaningful differences in safety or efficacy.

Garzulys was developed by Tonghua Dongbao Pharmaceutical in China together with companies linked to Meitheal, while the biologics licence application is held by Emerge Biosciences. Under a 2023 licence agreement, Meitheal serves as the US regulatory agent and holds exclusive commercial rights in the country. The company said the approval supports its broader plan to expand beyond generic injectables into biologics and branded medicines.

That strategy already includes Yusimry, its US Humira biosimilar, which Meitheal is marketing after the product was transferred from Coherus BioSciences to its Hong Kong-based parent company in 2024. The company has also said a higher-concentration version of Yusimry is in development, and it is working with Boan Biotech on denosumab biosimilars that have already been submitted to regulators. The FDA has repeatedly framed first generics and biosimilars as an important way to increase competition and broaden access to more affordable treatments.