US approves 1st fast-acting insulin biosimilar for diabetes

The US Food and Drug Administration approved the first-ever rapid-acting insulin for reducing blood sugar levels. 

It calls the new drug “Merilog,” a biosimilar to the widely-used insulin product Novolog (insulin aspart).

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The FDA defines a “biosimilar” as a product compared to another approved alternative known as a reference product. 

A biosimilar is highly similar to that reference with no clinically meaningful differences. 

Merilog reduces blood sugar spikes that occur during mealtime. Also, the FDA approved Merilog’s 3-milliliter single-patient-use prefilled pen and a 10-milliliter multiple-dose vial.

Patients must administer it subcutaneously or under the skin, typically in the abdomen, upper arms, thighs, or buttocks.

Its protocol suggests taking the drug approximately five to 10 minutes before a meal. However, healthcare providers will determine the dosing routine based on patient needs.

Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, lauded the Merilog approval:

“For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference.” 

“Biosimilar products have the potential to increase access to these life-saving medications,” she added.

The International Diabetes Foundation (IDF) says that the Philippines has 4,303,899 cases of diabetes in adults as of 2021.