FDA grants interchangeable status to Viatris' biosimilar insulin Semglee

The FDA announced Wednesday that Viatris' biosimilar insulin product Semglee (insulin glargine-yfgn) may now be substituted for its reference product, Sanofi's long-acting insulin analogue Lantus (insulin glargine), without the intervention of a prescriber. The agency noted that Semglee is the first interchangeable biosimilar insulin product available in the US.

Acting FDA Commissioner Janet Woodcock remarked that the approval "furthers [the agency's] longstanding commitment to support a competitive marketplace for biological products." She noted that "interchangeable biosimilar products have the potential to greatly reduce healthcare costs."

Priced at 65% discount

Semglee gained FDA approval in June last year, in both vial and pre-filled pen presentations, to control high blood glucose in adults with type 2 diabetes, as well as in adult and paediatric patients with type 1 diabetes. The treatment was authorised under the FDA's 505(b)(2) pathway after studies confirmed the pharmacokinetic/pharmacodynamic, efficacy, safety and immunogenicity of the insulin product in comparison to Lantus in patients with type 1 and 2 diabetes.

The product was subsequently launched by Viatris and partner Biocon at a 65% discounted list price, with a wholesale acquisition cost of $147.98 per package of five 3mL pens and $98.65 per 10mL vial. At the time, Viatris said that it had submitted all necessary documentation to the FDA seeking approval of Semglee as a biosimilar to Lantus under the 351(k) pathway.