FDA Approves Ziextenzo, the Third Neulasta Biosimilar for Febrile Neutropenia

The therapy is approved to decrease the incidence of infection due to febrile neutropenia in patients receiving myelosuppressive anti-cancer therapy.
BY Jessica Skarzynski
PUBLISHED November 05, 2019
The Food and Drug Administration (FDA) has approved the biosimilar to Neulasta (pegfilgrastim), Ziextenzo (LA-EP2006; pegfilgrastim-bmez) to decrease the incidence of infection due to febrile neutropenia in patients receiving myelosuppressive anti-cancer therapy.

Those being treated with chemotherapy run the risk of developing febrile neutropenia, a dangerously low white blood cell count, which then exposes them to a higher risk of serious infection.

In a statement announcing the decision, Carol Lynch, president of Sandoz Inc, the drug’s manufacturer, said, “When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy. The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option.”

The approval is based on data from analytical, preclinical and clinical studies that found Ziextenzo to have no clinically meaningful differences in safety and immunogenicity from Neulasta.

A biosimilar is a biological product that is highly similar to an already-approved biological product, and that has no clinically meaningful differences in terms of safety, purity and potency from the reference product. The FDA requires biosimilars to meet the agency’s rigorous approval standards. Agency approval means “patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar,” according to the FDA website.

This is the third Neulasta biosimilar to receive FDA approval, after Filphila (pegfilgrastim-jmdb) in June 2018 and Udenyca (pegfilgrastim-cbqv) in November 2018.

Check back later to learn more about how this approval will affect patients like you.
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