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Mylan And Biocon’s Semglee Insulin Glargine Approved In US

Product Deemed A Biologic By FDA; Launch May Be Imminent

 
• By Dean Rudge

Mylan and Biocon have received FDA approval for their Semglee insulin glargine product, with a path to market seemingly clear after Mylan emerged victorious in several recent patent-litigation challenges. Meanwhile, the firm continues to strive towards an interchangeability designation that would make it a much more valuable opportunity.

Lantus
Semglee 'has an identical amino acid sequence to Lantus,' Mylan underlined • Source: Shutterstock

Mylan and Biocon have received US Food and Drug Administration approval for their Semglee (insulin glargine) vial and pre-filled pen formulations, for which Mylan is continuing to fight to achieve an interchangeability designation with Sanofi’s Lantus (insulin glargine) multi-billion-dollar blockbuster.

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