{"id":631442,"date":"2025-02-21T10:18:08","date_gmt":"2025-02-21T15:18:08","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=631442"},"modified":"2025-02-21T10:18:08","modified_gmt":"2025-02-21T15:18:08","slug":"merilog-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/merilog-fda-approval\/","title":{"rendered":"FDA approves first rapid-acting insulin biosimilar"},"content":{"rendered":"

People with diabetes who need to use insulin now have another option to help manage blood sugar levels. The U.S. Food and Drug Administration (FDA) approved Merilog (insulin-aspart-szjj) to improve glycemic control in adults and children with diabetes.\u00a0<\/span><\/p>\n

It\u2019s the first rapid-acting insulin product that is a biosimilar for NovoLog (insulin-aspart).<\/span><\/p>\n

Manufactured by Sanofi, Merilog joins two long-acting insulin biosimilar products that were approved by the FDA in 2021: <\/span>Rezvoglar<\/span><\/a> (insulin glargine-aglr) and <\/span>Semglee<\/span><\/a> (insulin glargine-yfgn).<\/span><\/p>\n

\u201cFor 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, as biosimilar products have the potential to increase access to these life-saving medications,\u201d Dr. Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA\u2019s Center for Drug Evaluation and Research, said in a statement.\u00a0<\/span><\/p>\n

How Merilog works<\/span><\/h2>\n

According to the FDA, about 8.4 million people in the U.S. use insulin to help manage diabetes. For people with this condition, the pancreas doesn\u2019t make enough of this particular hormone to help move sugar from the bloodstream into the cells, where it can be used for energy. As a result, the levels of glucose in the bloodstream stay high, which can damage blood vessels and nerves over time\u2014and lead to other serious health conditions.\u00a0<\/span><\/p>\n

Merilog is a fast-acting or rapid-acting insulin that replaces the insulin the body does not produce. It is <\/span>injected under the skin about five to ten minutes before eating a meal<\/span><\/a> and starts working about 15 minutes later. The effect will peak about an hour or two after injection and last about two to four hours.\u00a0<\/span><\/p>\n

Merilog will be available in two forms: a 10 mL multi-dose vial and a 3 mL single-patient-use prefilled pen. The pen dials in one-unit increments, allowing you to customize the amount of rapid-acting insulin you need, taking into account factors such as physical activity or changes in mealtime.\u00a0<\/span><\/p>\n

Appropriate injection sites for Merilog include the upper arm, the abdominal area, the thigh, or the buttocks. However, it\u2019s important to rotate the injection site so that you don\u2019t inject into the same location every single time.\u00a0<\/span><\/p>\n

What are biosimilars?<\/span><\/h2>\n

Biosimilars<\/span><\/a> are medications that the FDA considers to be highly similar, with no major clinical differences, to another biological product that is already approved. The original is often called the reference product. In this case, Merilog functions like Novo Nordisk\u2019s NovoLog, which is the reference product. Manufacturers must prove that biosimilars are just as safe and effective as their reference products\u2013and can be given at the same dosage.\u00a0<\/span><\/p>\n

As with generic drugs, when biosimilar products are approved, there is more competition in the market, which can help drive down prices. Typically, biosimilars cost less than the original product. <\/span>One study reported<\/span><\/a>, \u201cPrices for biosimilars are typically 15% to 35% lower than their respective brand-name reference biologic and can prompt the brand-name manufacturers to lower prices or offer discounts.\u201d<\/span><\/p>\n

What are the side effects of Merilog?<\/span><\/h2>\n

Some potential adverse reactions can occur when taking an insulin aspart product like Merilog, which can include:<\/span><\/p>\n