Viatris Stock Gains After FDA Approves Viatris-Biocon Biologics' Insulin Glargine Biosimilar Injection

The FDA cleared Viatris inc VTRS - Biocon Biologics' Semglee insulin glargine-yfgn injection as a biosimilar.
Semglee indicates controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes.
The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
The product is sold in a pre-filled disposable pen.
According to the release, the interchangeable product will allow for the substitution of Semglee for the reference product, Lantus, at the pharmacy counter. It will be introduced before the end of 2021.
The Company is eligible for 12 months of exclusivity before the FDA can approve another biosimilar interchangeable to Lantus.
Price Action: VTRS shares are up 3.87% at $14.78 during the premarket session on the last check Thursday.
Related content: Benzinga's Full FDA Calendar.