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# Sandoz Neulasta Biosimilar Approved
- URL: https://www.fdaweb.com/sandoz-neulasta-biosimilar-approved/
- Published: 2019-11-06T12:00:00.000Z
- Updated: 2026-09-14T15:52:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145441

FDA has approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen’s Neulasta (pegfilgrastim) for decreasing the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Approval was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104).2 This study compared Sandoz’s pegfilgrastim with a U.S.-sourced reference pegfilgrastim, Sandoz’s pegfilgrastim with an EU-sourced reference pegfilgrastim, and a U.S.-sourced with EU-sourced reference pegfilgrastim. “PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups,” the company says.

In April, Sandoz resubmitted the BLA to address a 6/2016 complete response letter ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5136219&searchWords=pegfilgrastim&cate=S&stid=%241%24HB5.EG%2F.%248NzVogEMTnGkdxtRh2o5u%2F&ref=fdaweb.com)). The resubmission, the company said at the time, included new data from a pivotal pharmacokinetics and pharmacodynamics study. 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.