Friday, October 02, 2015

FDA accepts Sandoz's application for biosimilar Etanercept despite Amgen maintaining Enbrel exclusivity to 2029

  • Sandoz has announced it is seeking approval for all indications included in the Enbrel label
  • The is first time the FDA has accepted a submission for a biosimilar version of etanercept
  • Filing is supported by studies including EGALITY which enrolled patients with psoriasis
  • Sandoz recently launched Zarxio, a biosimilar filgrastim

For our coverage of EADV next week please contact

Comments:  This filing is interesting for a number of reasons but we believe the fact that etanercept is administered sc over chronic periods makes this particularly interesting.  For the first time in the US there will there be a good opportunity for a biosimilar company to test the waters with a product that can be differentiated by administration device and also by patients support programs.  It will be intriguing to see how Sandoz handles this.  This is all the more notable given that its parent company, Novartis has recently launched Cosentyx for psoriasis with a state of the art device which could be potentially used to differentiate Sandoz's etanercept from Enbrel and the Enbrel pen.  The timing of Sandoz's announcement is also convenient with EADV coming up next week.  Perhaps the most interesting aspect of today's news is that the general assumption has been Amgen's exclusivity on Enbrel runs to 2029 in the US.  A key question is therefore, why exactly has Sandoz chosen to file now.

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