Mylan Prepares To Launch Insulin Glargine After Another Lantus IP Win
IPR Victory In US Follows Favorable District Court Ruling In March
Mylan says it is now ready to launch its Semglee insulin glargine rival to Sanofi’s Lantus in the US upon FDA approval, after removing the final intellectual-property barriers by way of a favorable inter partes review decision.
You may also be interested in...
After receiving “positive feedback” from the US Food and Drug Administration on its biosimilar insulin glargine, Lannett plans to move forward with its development activity.
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.
Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.