FDA Approves First Rapid-Acting Biosimilar Insulin for Diabetes Treatment
In a significant milestone for diabetes management, the U.S. Food and Drug Administration (FDA) has granted approval to Merilog (insulin aspart szij), marking it as the first biosimilar rapid-acting insulin designed to assist those affected by diabetes. This groundbreaking product aims to enhance glycemic control, specifically for adult and pediatric patients suffering from diabetes mellitus. Merilog is classified as a human insulin analog that works rapidly, effectively mitigating blood sugar spikes during meal times, hence improving blood sugar control for diabetic patients.
The FDA's nod comes with two presentation forms: a 3-milliliter (ml) pre-filled pen for single use by patients and a 10-milliliter (ml) multi-dose vial. Notably, Merilog becomes the third biosimilar insulin to gain approval from the FDA; the agency previously sanctioned two prolonged-action insulin biosimilars back in 2021. The availability of biosimilar products has the potential to broaden patient access to safe and effective treatment options.
Dr. Peter Stein, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, stated, "To date, the FDA has approved three biosimilar insulin products for diabetes treatment. This approval underscores our continuous efforts to enhance the biosimilars approval process, fostering a competitive market while providing patients with more affordable treatment alternatives. Ensuring patients have access to safe, effective, and high-quality medications at potentially lower costs remains a steadfast priority for the FDA."
Biologics encompass medications addressing many severe diseases and chronic conditions, including diabetes. A biosimilar is a biological product that closely resembles an already approved biological product (the reference product), posing no clinically significant differences. Henceforth, patients can expect similar safety and efficacy from the biosimilar as with the reference product. As of now, the FDA has approved 65 biosimilar products targeting various health conditions.
Currently, over 38 million individuals in the United States are diagnosed with diabetes, a condition characterized by abnormally high glucose (sugar) levels in the blood. Approximately 8.4 million require insulin—either rapid- or long-acting—for effective diabetes management. Insulin acts as a facilitating agent, helping glucose penetrate the cells for energy utilization. Patients with diabetes often experience insufficient insulin production from the pancreas, leading to exceedingly high blood sugar, which can cause severe health complications.
Dr. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA, emphasized, "For millions reliant on daily insulin injections for diabetes treatment, the introduction of a biosimilar for rapid-acting insulin can truly be life-changing. Biosimilars hold the potential to expand access to these critical, lifesaving medications."
Similar to Novolog, Merilog must be administered between five and ten minutes before meal initiation and is given subcutaneously (under the skin) via injection in the abdomen, thighs, the upper arms, or buttocks. The administration of Merilog should be personalized and adjusted based on the patient's specific needs.
While Merilog offers numerous benefits, it can also lead to severe side effects, including hypoglycemia (low blood sugar levels), severe allergic reactions, and hypokalemia (low potassium levels). More common side effects may include reactions at the injection site, itching, skin rashes, lipodystrophy (thickening or denting of the skin at the injection site), weight gain, and swelling in the hands and feet.
Merilog has been developed and approved for use by Sanofi-Aventis U.S. LLC. As the FDA oversees the security of the U.S. food and drug supply, it ensures the safety, efficacy, and quality of medications intended for human use, extending to biologicals and medical devices alongside food supplies and tobacco products.
The FDA's nod comes with two presentation forms: a 3-milliliter (ml) pre-filled pen for single use by patients and a 10-milliliter (ml) multi-dose vial. Notably, Merilog becomes the third biosimilar insulin to gain approval from the FDA; the agency previously sanctioned two prolonged-action insulin biosimilars back in 2021. The availability of biosimilar products has the potential to broaden patient access to safe and effective treatment options.
Dr. Peter Stein, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, stated, "To date, the FDA has approved three biosimilar insulin products for diabetes treatment. This approval underscores our continuous efforts to enhance the biosimilars approval process, fostering a competitive market while providing patients with more affordable treatment alternatives. Ensuring patients have access to safe, effective, and high-quality medications at potentially lower costs remains a steadfast priority for the FDA."
Biologics encompass medications addressing many severe diseases and chronic conditions, including diabetes. A biosimilar is a biological product that closely resembles an already approved biological product (the reference product), posing no clinically significant differences. Henceforth, patients can expect similar safety and efficacy from the biosimilar as with the reference product. As of now, the FDA has approved 65 biosimilar products targeting various health conditions.
Currently, over 38 million individuals in the United States are diagnosed with diabetes, a condition characterized by abnormally high glucose (sugar) levels in the blood. Approximately 8.4 million require insulin—either rapid- or long-acting—for effective diabetes management. Insulin acts as a facilitating agent, helping glucose penetrate the cells for energy utilization. Patients with diabetes often experience insufficient insulin production from the pancreas, leading to exceedingly high blood sugar, which can cause severe health complications.
Dr. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA, emphasized, "For millions reliant on daily insulin injections for diabetes treatment, the introduction of a biosimilar for rapid-acting insulin can truly be life-changing. Biosimilars hold the potential to expand access to these critical, lifesaving medications."
Similar to Novolog, Merilog must be administered between five and ten minutes before meal initiation and is given subcutaneously (under the skin) via injection in the abdomen, thighs, the upper arms, or buttocks. The administration of Merilog should be personalized and adjusted based on the patient's specific needs.
While Merilog offers numerous benefits, it can also lead to severe side effects, including hypoglycemia (low blood sugar levels), severe allergic reactions, and hypokalemia (low potassium levels). More common side effects may include reactions at the injection site, itching, skin rashes, lipodystrophy (thickening or denting of the skin at the injection site), weight gain, and swelling in the hands and feet.
Merilog has been developed and approved for use by Sanofi-Aventis U.S. LLC. As the FDA oversees the security of the U.S. food and drug supply, it ensures the safety, efficacy, and quality of medications intended for human use, extending to biologicals and medical devices alongside food supplies and tobacco products.
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