Blog 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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