BREAKING NEWS: FDA Approves Sandoz’s Erelzi, biosimilar to Enbrel (etanercept)

Approved Biosimilar Products  •  Biosimilar News  •  Immunex v. Sandoz (etanercept)

The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept).   Sandoz’s biosimilar is called Erelzi.  It is the first biosimilar etanercept approved by FDA, and the third product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars (first was Sandoz’s Zarxio (filgrastim) biosimilar to Amgen’s Neupogen, second was Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab)).

Sandoz’s etanercept product is currently the subject of litigation in Immunex v. Sandoz, in which a stipulated preliminary injunction has been entered by agreement of the parties.

 

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