The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novo Nordisk’s NovoLog (insulin aspart), called NovoRapid outside of the US, for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.  

Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by FDA and the third insulin biosimilar product approved by FDA. The other two insulin biosimilars approved by FDA are long-acting insulins, Biocon’s Semglee (insulin glargine-yfgn) and Eli Lilly and Company’s Rezvoglar (insulin glarergine-aglr), both first approved by FDA in 2021, as biosimilars to Sanofi’s long-acting insulin product, Lantus (insulin glargine). Lantus posted 2024 sales of EUR 1.6 billion ($1.7 billion). 

As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3-mL-single-patient-use prefilled pen and a 10-mL multiple-dose vial. 

Source: US Food and Drug Administration