FDA Approves a Sandoz Biosimilar for Neulasta

Ziextenzo helps lower the incidence of febrile neutropenia

The FDA has approved pegfilgrastim-bmez (Ziextenzo, Sandoz), the third biosimilar of Neulasta (Amgen), which is widely prescribed to fight the serious chemotherapy side effect called febrile neutropenia. Ziextenzo has been marketed in Europe since 2018, and Sandoz expects to launch it in the U.S. as soon as possible.

Pegfilgrastim-bmez is indicated to decrease the incidence of infection as manifested by febrile neutropenia (a low white blood cell count with a fever) in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Each year, more than 60,000 U.S. cancer patients are hospitalized with evidence of neutropenia, including fever or infection, resulting in more than 4,000 deaths.

The FDA approval of Ziextenzo was based on analytical, preclinical, and clinical research that found no clinically meaningful differences between the new product and reference samples of pegfilgrastim obtained in both the U.S. and European Union.

The FDA approved pegfilgrastim-jmdb (Fulphila, Mylan) in June 2018 and pegfilgrastim-cbqv (Udenyca, Coherus BioSciences) in November 2018. Although its new biosimilar will be the third to reach the market, Sandoz (a division of Novartis) notes that it is the first and only company to offer U.S. physicians the choice between a long- and short-acting biosimilar filgrastim treatment. Sandoz’s short-acting filgrastim Zarxio is the leading filgrastim by market share in the U.S.

Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) produced by a person's own body.

.Sources: Sandoz, November 5, 2019; FDA biosimilar list, November 5, 2019