Shots:
- The CHMP has recommended Ondibta, a biosimilar insulin glargine pre-filled pen for pts (age≥ 2), reference medicine Lantus SoloStar. The EC will now review the opinion, and approval is anticipated across the EU and EEA states
- Insulin glargine is a long-acting, once-daily basal insulin analog that provides up to 24 hours of steady, peakless glucose-lowering activity
- Ondibta completed head-to-head P-III trials in both the EU and the US against Lantus, with studies in over 1,100 pts showing similar efficacy and safety to the reference medicine. The company also confirmed biosimilarity between its insulin glargine U300 and Toujeo through a glucose-clamp PK/PD study
Ref: Gan & Lee | Image: Gan & Lee | Press Release
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