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.

Here are three things to know.

1. Merck's biosimilar, Lusdana Nexvue, is an insulin injection available in a pre-filled dosing device.
   
   

2. Sanofi sued Merck in September, claiming Lusdana infringed on Lantus' patent rights.
   
   

3. 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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