On November 5, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim, pegfilgrastim-bmez (Ziextenzo).
Pegfilgrastim-bmez is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to the natural protein granulocyte-colony stimulating factor.
A study by Caggiano et al in Cancer found that each year in the United States, more than 60,000 patients with cancer are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result.
The approval of pegfilgrastim-bmez was based on analytical, preclinical, and clinical research, including data from a pivotal three-way pharmacokinetics and pharmacodynamics study (LA-EP06-104). This study compared pegfilgrastim-bmez with U.S.-sourced reference pegfilgrastim, pegfilgrastim-bmez with reference pegfilgrastim sourced from the European Union (E.U.), and U.S.-sourced with E.U.-sourced reference pegfilgrastim. Pharmacokinetic and pharmacodynamic similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.