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FDA Approves Sandoz's Pegfilgrastim Biosimilar

Gina Columbus @ginacolumbusonc
Published: Tuesday, Nov 05, 2019

The FDA has approved the pegfilgrastim (Neulasta) biosimilar LA-EP2006 (pegfilgrastim-bmez; Ziextenzo) as a treatment to decrease the incidence of infection, exhibited from febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy that is associated with a clinically significant incidence of febrile neutropenia.1

The approval is based on analytical, preclinical, and clinical studies, including data from the pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) LA-EP06-104 trial comparing Sandoz's pegfilgrastim biosimilar with US-sourced reference pegfilgrastim; the pegfilgrastim biosimilar with European Union–sourced reference pegfilgrastim; and US- with EU-sourced reference pegfilgrastim.2 Results showed that PK and PD similarity were demonstrated in all three comparisons, and there were no clinically meaningful differences observed in safety and immunogenicity among the groups.

"When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy," Carol Lynch, president of Sandoz Inc., the developer of the biosimilar, stated in a press release. "The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio—the leading filgrastim by market share in the US—including consistent product supply and reliable patient services."

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