medwireNews: The US FDA has approved insulin glargine-yfgn, the first interchangeable biosimilar insulin product, for the treatment of adults and children with type 1 diabetes and adults with type 2 diabetes.
This approval is based on evidence showing that the biosimilar is “highly similar” to insulin glargine, a long-acting insulin analog, with “no clinically meaningful differences” in safety and efficacy. Moreover, switching to the biosimilar is not associated with risks in terms of safety or diminished efficacy, says the FDA.
Writing in a press release, Acting FDA Commissioner Janet Woodcock said that “biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” and described the approval as “momentous.”
Insulin glargine-yfgn is available in 10 mL vials and 3 mL prefilled pens, and is administered once daily by subcutaneous injection.
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