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 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.

A US district court has ruled in favor of Mylan in a dispute with Sanofi over a Lantus SoloStar device patent, with the patent protecting the insulin glargine injector pen found to be invalid and not infringed. Mylan, along with partner Biocon, expects to launch its Semglee version mid-year, following FDA approval.