After receiving the green light from US regulators, Sandoz is readying a commercial launch for its biosimilar Ziextenzo (pegfilgrastim-bmez).
Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018.
Ziextenzo is indicated to decrease 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.
The FDA 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).
This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-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.