Despite scoring an FDA nod, Merck's biosim Lusduna must wait to challenge Lantus

Fierce Pharma ------- Sanofi’s top-selling Lantus is already contending with one copycat rival, and Merck & Co. just won FDA approval for another. Luckily for the $5 billion basal insulin, Merck’s new Lusduna Nexvue has to sit on the sidelines for now—and maybe for more than a year. Sanofi sued Merck for patent infringement last September, triggering an automatic 30-month stay under the Hatch-Waxman Act, which governs generic drugs’ path to market. The two companies will be squaring off in patent court in the meantime, though, and if Merck prevails, the launch can proceed. To learn more click on the picture below to read the article.