The U.S. Food and Drug Administration (FDA) approved the biosimilar agent Ziextenzo™ (pegfilgrastim-bmez) to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
This agent has demonstrated similarity between Neulasta® (pegfilgrastim), the biologic reference product.
No clinically significant differences
The approval was based on analytical, preclinical, and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study that compared pegfilgrastim-bmez with the reference product pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and there were no clinically meaningful differences observed regarding safety and immunogenicity among the treatment groups.
Pegfilgrastim-bmez has been approved and marketed in Europe since 2018. The FDA previously approved another biosimilar for febrile neutropenia, Zarxio® (filgrastim-sndz).