FDA Approves Biosimilar for Common Insulin

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar insulin product.

The approval is for Semglee (insulin glargine-yfgn). The FDA approved this drug to improve blood sugar control in:

This insulin is approved to be a substitute for Lantus (insulin glargine), a long-acting insulin. The FDA approved it as a biosimilar.

A biosimilar is a biological product that is highly similar to another biological product that has already been approved. This already approved product is known as a reference product. And in this case, the reference product is Lantus.

An interchangeable biosimilar product means the pharmacy can substitute the biosimilar for the reference product in the same way generic drugs are substituted for brand name drugs.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Dr. Janet Woodcock in a press release.

Often, biosimilar and interchangeable biosimilar products offer patients cost-effective options. In fact, biosimilars typically have an initial list price between 15 and 35 percent lower than their reference products, according to the FDA.

Semglee is injected under the fatty layer of the skin (subcutaneously) once daily. Like its reference product, Lantus, Semglee’s dose is to be individualized based on the patient’s needs.

Common side effects of Semglee may include fluid retention, pitting at the injection site and weight gain. This medication can also cause allergic reactions, such as injection-site reactions (rash, redness, pain and severe itching).

This drug can lead to serious side effects, including low blood sugar, severe allergic reactions, low potassium in the blood and heart failure.

The FDA granted approval of this insulin to Mylan Pharmaceuticals Inc.

Talk to your health care provider before making any changes to your diabetes treatment regimen.