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The product is the first interchangeable insulin biosimilar approved by the FDA.
The first interchangeable insulin biosimilar approved by the Food and Drug Administration has launched.
According to a news release, Biocon Biologics Ltd. And Viatris Inc. have launched the branded injectable SEMGLEE and the unbranded Insulin Glargine on the U.S. market to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2. Both products are available in vial and prefilled pen presentations and are interchangeable for LANTUS.
“The launch of our interchangeable biosimilar insulin glargine in the U.S. by our partner Viatris is in line with our aspiration to provide our biosimilar insulins to ‘one in five’ insulin dependent people with diabetes, globally,” Shreehas Tambe, deputy CEO of Biocon Biologics. “This is indeed a landmark event and along with the recent formulary listings, we believe it will allow us to improve accessibility, availability and adoption of biosimilars in the U.S. for the benefit of patients and the overall healthcare system.”
As previously reported, Semglee (insulin glargine-yfgn), is indicated to improve glycemic control in adults and children with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. It is both biosimilar to and can be substituted for its reference product, long-acting insulin analog Lantus (insulin glargine). This is the first insulin biosimilar approved by the FDA and these products can give patients more safe, high-quality, and possibly cost-effective options to treat diabetes.
Biosimilars are biological products with no clinically meaningful difference from a product already approved by the FDA. Interchangeable biosimilars can be substituted for their reference product without direct action by the prescriber. When marketed in the U.S., biosimilars usually launch with initial list prices 15 percent to 35 percent lower than the list prices of the reference product.
At the time of its approval, then-Acting FDA Commissioner Janet Woodcock, MD, touted the possibility of the new product making diabetes management more affordable.
“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,” Woodcock said. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”