FDA Approves Mylan Semglee Biosimilar Insulin Product

FDA has approved Mylan’s Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes and adults with Type 2 diabetes. An agency notice says Semglee is biosimilar to and interchangeable with Sanofi’s Lantus (insulin glargine), a long-acting insulin analog that is its reference product.

The approval of Semglee as biosimilar to and interchangeable with Lantus was based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between them in safety, purity, and potency, FDA says. The notice says it also showed that Semglee can be expected to produce the same clinical result as Lantus in any given patient and that the risk in terms of safety or diminished efficacy of switching between Semglee and Lantus is not greater than the risk of using Lantus without such switching.