FDA has authorised Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.
On July 28, 2021, FDA authorized Mylan Pharmaceuticals’ Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product inside the United States for treating diabetes. The product is indicated for improving glycemic manipulate in adults and pediatric sufferers with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee is both biosimilar to and interchangeable with its reference product, Lantus (insulin glargine), a protracted-performing insulin analog.
According to FDA, an interchangeable biosimilar product may be substituted for the reference product and does now not require the intervention of a prescriber. Substitution may occur at pharmacy level, similar to how everyday pills are substituted for brand call pills, challenge to nation pharmacy legal guidelines, which vary by nation. Similar to familiar-drug price savings, biosimilar and interchangeable biosimilar products have the capacity to lessen health care expenses. Biosimilars advertised within the US have generally released at preliminary list charges that are 15% to 35% decrease than comparative listing expenses of the reference product, the organization said in a press launch.
The approval of Semglee is based totally on evidence that confirmed it’s miles surprisingly much like the reference product, Lantus, and that there aren’t any clinically significant differences among the 2 in terms of protection, purity, and potency. Evidence additionally showed that Semglee may be expected to provide the same clinical result as Lantus and that the safety and efficacy risks in switching from Lantus to Semglee are no more than the risks of using Lantus without switching.
“This is a momentous day for folks who depend each day on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar merchandise have the capacity to substantially reduce fitness care costs,” stated Acting FDA Commissioner Janet Woodcock in the press release. “Today’s approval of the primary interchangeable biosimilar product furthers FDA’s longstanding commitment to support a aggressive market for organic products and in the long run empowers sufferers by means of supporting to increase get admission to to safe, effective, and brilliant medicines at potentially decrease price.”
“Access to inexpensive insulin is crucial, and long-acting insulin products, [such as] insulin glargine, play an important position within the remedy of Types 1 and a pair of diabetes mellitus,” stated Peter Stein, director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. “[FDA’s] high requirements for approval imply fitness care professionals and patients can be assured inside the safety and effectiveness of an interchangeable biosimilar product, simply as they might for the reference product.”