FDA Approves Sandoz’s Biosimilar Pegfilgrastim

As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its application after reportedly addressing the issues identified by FDA.  Yesterday, the FDA approved Sandoz’s application.  The biosimilar, named ZIEXTENZO, is an injectable formulation of pegfilgrastim-bmez, with a strength of 6 mg/0.6 mL.  The Federal Circuit previously upheld a district court non-infringement ruling in Sandoz’s favor regarding its pegfilgrastim biosimilar.