31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to clinch the marketing aspect.
Biocon Biologics and Mylan said they have launched the long-acting insulin glargine product Semglee on the US market and hope to obtain formal biosimilar status for it.
Semglee was approved in June as an equivalent to Sanofi’s Lantus insulin glargine, but not as a biosimilar, owing to the regulatory pathway taken.