FDA grants tentative approval to Merck’s diabetes biosimilar

Merck on Thursday earned tentative Food and Drug Administration approval for its biosimilar version of Sanofi’s diabetes drug Lantus.

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Here are three things to know.

  1. Merck’s biosimilar, Lusdana Nexvue, is an insulin injection available in a pre-filled dosing device.
  1. Sanofi sued Merck in September, claiming Lusdana infringed on Lantus’ patent rights.
  1. The lawsuit prevents the FDA from issuing a final approval for Lusdana Nexvue for up to 30 months or until a court rules in favor of Merck, whichever occurs sooner.

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