This marks a significant milestone as Merilog becomes the first rapid-acting insulin biosimilar authorized by the FDA, providing more options for patients managing their diabetes.
Merilog is a rapid-acting human insulin analog designed to reduce spikes in blood sugar levels that typically occur during mealtime.
This approval extends to a 3-milliliter single-patient-use prefilled pen and a 10-milliliter multiple-dose vial, making it readily accessible for personal and clinical use.
The introduction of Merilog is particularly notable given that it is the third insulin biosimilar approved in the U.S., following the approval of two long-acting insulin biosimilars in 2021.
Dr. Peter Stein, the director of the FDA’s Office of New Drugs, commented on the agency’s ongoing efforts to facilitate the biosimilar approval.
“Today’s approval underscores our commitment to fostering a competitive market and expanding access to affordable treatments such as insulin,” he stated.
The FDA’s emphasis on enhancing the availability of high-quality medications is seen as a critical measure in addressing the needs of the millions of people affected by diabetes.
Diabetes remains a pressing public health issue in the United States, with over 38 million individuals diagnosed with the condition.
Approximately 8.4 million rely on insulin therapy to effectively manage their blood glucose levels. Insulin enables glucose to enter the body’s cells, providing necessary energy.
In people with diabetes, insufficient insulin production can lead to dangerously high blood sugar levels, resulting in serious complications over time.
