The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for the improvement of glycaemic control in both adults and paediatric patients with diabetes mellitus. 

Merilog is the first rapid-acting insulin biosimilar approved by the FDA.

This approval expands the availability of insulin products and follows the approval of two long-acting insulin biosimilars in 2021, providing patients with more treatment options. 

Merilog offers a biosimilar alternative to Novolog, meaning it is highly similar to the reference product, with no clinically significant differences in safety or effectiveness. 

The FDA emphasizes that biosimilars like Merilog provide an opportunity to increase patient access to high-quality, safe medications at a potentially lower cost.

However, like other insulin products, Merilog may cause serious side effects such as hypoglycemia, allergic reactions, and hypokalemia. Other common side effects include injection site reactions, weight gain, and lipodystrophy.

This approval is a part of the FDA’s ongoing efforts to reduce the cost of diabetes treatments, empowering patients by increasing access to affordable options.

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