Prepared by Christine Yu and Amit Lahoti
Semglee™ is a new biosimilar insulin with an identical amino-acid sequence to insulin glargine. Semglee™, co-developed by Mylan Inc. and Biocon Ltd., was approved by the FDA on June 11, 2020. Semglee™ joins the original insulin glargine (Lantusâ) and another biosimilar product (Basaglarâ) on the US market, allowing for competition and anticipated cost-savings to the consumer. It is approved for children and adults with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Semglee™ will be sold as 10-mL vials and 3-mL pre-filled pen devices and has the same listed inactive ingredients as the other marketed brands of insulin glargine in vial and pen form.