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# Sandoz Re-files Biosimilar Neulasta BLA
- URL: https://www.fdaweb.com/sandoz-re-files-biosimilar-neulasta-bla/
- Published: 2019-04-03T12:00:00.000Z
- Updated: 2026-09-15T01:17:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143782

Novartis says its Sandoz drug unit has resubmitted its biosimilar pegfilgrastim (Amgen’s Neulasta) BLA to address a 6/2016 complete response letter ([see earlier story](https://www.fdaweb.com/sandoz-given-complete-response-on-neulasta-biosimilar/)). The resubmission, the company says, includes new data from a pivotal pharmacokinetics and pharmacodynamics study. “This was a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with U.S.-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and U.Ss with EU-sourced reference pegfilgrastim,” it says. Pegfilgrastim is a long-acting version of filgrastim and is prescribed to appropriate cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells.