Mylan And Biocon’s Semglee Insulin Glargine Approved In US

Product Deemed A Biologic By FDA; Launch May Be Imminent

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.

Launch timing was not crystalized by either firm, but Mylan observed that its previous successes in toppling Sanofi’s intellectual property meant any appeals from the originator were not, in Mylan’s opinion,

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