Big Molecule Watch
April 11, 2019

Sandoz Resubmits Its Biosimilar Pegfilgrastim Application

Last week, Sandoz announced the resubmission of its Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim).  The resubmission is to address an FDA complete response letter that Sandoz received in June 2016.  According to the press release, the resubmission includes new data from a pivotal pharmacokinetics/pharmacodynamics study.  The study compared:  (1) Sandoz’s pegfilgrastim with US-sourced reference pegfilgrastim; (2) Sandoz’s pegfilgrastim with EU-sourced reference pegfilgrastim; and (3) US-sourced reference pegfilgrastim with EU-sourced reference pegfilgrastim.

Last November, the European Commission approved Sandoz’s pegfilgrastim biosimilar (Ziextenzo®), indicated “to reduce duration of neutropenia/incidence of febrile neutropenia, some of the most serious side effects of chemotherapy.”

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