On August 31, 2020 Mylan and Biocon Biologics announced the long-awaited US launch of Semglee, a new insulin aiming to be deemed “biosimilar” to insulin glargine (basal insulin) by the FDA at a price point that is approximately 65% less than Lantus and 50% below the current price of Basaglar.
The FDA has yet to classify Semglee as “biosimilar” or “interchangeable” to Lantus due to the need for additional review – so for now, Semglee should be considered a new basal insulin option for people with diabetes.
Semglee (insulin glargine) gained FDA approval on June 11, 2020 based on a comprehensive analytical, preclinical, and clinical program review which confirmed the pharmacokinetic and pharmacodynamic efficacy, safety, and immunogenicity in comparison to Lantus in patients with Type 1 and Type 2 diabetes.
The dosing for Semglee is identical to Basaglar and Lantus that is currently used to manage your patients.
A Prior Authorization will be required for Basaglar insulin effective December 1, 2020
Please issue a new prescription for Semglee for CHA patients currently on Lantus or Basaglar to ensure uninterrupted coverage.