Biocon and Viatris get FDA approval for interchangeable biosimilar drug for diabetes

The USFDA today announced the approval given to Biocon Biologics, a subsidiary of Bengaluru-based Biocon Limited, and Viatris, for an interchangeable biosimilar to treat diabetes. The interchangeable Semglee product, will allow substitution of Semglee for the reference product, Lantus, at the pharmacy.

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber.

The medicine is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

"This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine", Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw.

The US FDA stated, "The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and interchangeable with Lantus (insulin glargine), is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) in terms of safety, purity and potency (safety and effectiveness)."

It went on to state that Semglee (insulin glargine-yfgn) can be expected to produce the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) is not greater than the risk of using Lantus (insulin glargine) without such switching.