FDA Approves First Fast-Acting Insulin Biosimilar for Diabetes Treatment

The U.S. Food and Drug Administration (FDA) has recently approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart), marking a significant development in the treatment options available for individuals with diabetes mellitus. This approval is noteworthy as Merilog is the first rapid-acting insulin biosimilar authorized by the FDA. It is designed to improve glycemic control by mitigating blood sugar spikes following meals in both adults and children with diabetes. The product is available in the form of a 3 mL prefilled pen for single-patient use and a 10 mL vial for multiple doses.

The introduction of Merilog expands the FDA's list of approved insulin biosimilars to three, following the approval of two long-acting insulin biosimilars in 2021. The aim of such biosimilar approvals is to enhance patient access to effective and safe therapeutic options. Dr. Peter Stein, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, emphasized the importance of making treatment options like insulin more accessible and affordable, highlighting the FDA's commitment to supporting a competitive market.

Biosimilars are biological medications that are highly similar to already approved products known as reference products, with no significant clinical differences. Patients using biosimilars can anticipate the same level of safety and efficacy as with the original product. The FDA has so far approved 65 biosimilars for various health conditions, reflecting the growing acceptance and utilization of these products.

Diabetes affects over 38 million people in the United States, with approximately 8.4 million relying on insulin therapy, whether rapid-acting or long-acting. Insulin plays a critical role in helping cells utilize glucose for energy, and insufficient insulin levels can lead to severe health complications. Dr. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars, expressed optimism that a biosimilar like Merilog could significantly enhance access to vital insulin therapies for patients.

Merilog should be administered subcutaneously, ideally five to ten minutes before meals, through injections into the stomach, buttocks, thighs, or upper arms. Dosages need to be personalized and adjusted according to individual patient needs. Despite its benefits, Merilog may cause serious side effects, including hypoglycemia, severe allergic reactions, and low potassium levels. Other potential side effects include localized reactions at the injection site, itching, rashes, skin changes, weight gain, and swelling of the extremities.

Sanofi-Aventis U.S. LLC has been granted the approval of Merilog by the FDA. As an ongoing effort, the FDA continues to ensure the safety, effectiveness, and availability of human and veterinary drugs, as well as other biological products for human use. In addition to drugs, the agency also oversees the safety of food, cosmetics, dietary supplements, radiation-emitting devices, and tobacco products in the United States, thereby upholding public health standards across multiple sectors.