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Novartis: Sandoz' Biosimilar Ziextenzo Gets FDA Approval

Sandoz Inc., the generics division of Swiss drug maker Novartis AG, announced Tuesday that the US Food and Drug Administration approved its long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez).

Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy.

The FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics and pharmacodynamics study.

Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.

With the approval, Sandoz is the first and only company to offer US physicians long- and short-acting filgrastim biosimilar treatment options. The company now has four US approved biosimilars.

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