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Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®

Feb 14, 2025

On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart), for the improvement of glycaemic control in adults and paediatric patients with diabetes mellitus.

Merilog™/Merilog™ SoloStar are the first rapid-acting insulin biosimilars to be approved in the US.  There were two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).