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Biocon's Semglee gets USFDA approval; first interchangeable biosimilar product in US


Biocon s Semglee gets USFDA approval; first interchangeable biosimilar product in US
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Last Updated: Jul 29, 2021, 09:56 AM IST
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Synopsis
“It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine,” Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said in a statement.
The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
Biocon Biologics Ltd, a unit of Biocon and Viatris Inc said on Thursday that the U.S. Food and Drug Administration (FDA) has approved its insulin glargine-yfgn injection branded Semglee in the US market. ....

Kiran Mazumdar Shaw , Arun Chandavarkar , Biocon Biologics , Viatris Biocon Biologics , Biologics Ltd , Drug Administration , Viatris Inc , Biosimilar Insulin Glargine , Executive Chairperson , Biologics Managing Director Arun Chandavarkar , Biocon Biologic , கிறன் மஜும்தர் ஷா , அருண் சாண்டவர்கள் , பயோகான் உயிரியல் , உயிரியல் லிமிடெட் , நிர்வாகி தலைவர் ,