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Gan & Lee Pharmaceuticals Gains the CHMP’s Positive Opinion for Ondibta (Biosimilar, Lantus SoloStar) 

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…

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