FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sandoz Gains Eighth EU Biosimilar Approval

Dec. 10, 2018
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The European Commission approved Sandoz’s Ziextenzo (pegfilgrastim), marking the Novartis subsidiary’s eighth biosimilar approval granted by the commission.

The drug — which references Neulasta — is intended to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukemia and myelodysplastic syndromes.

Sandoz received four other biosimilar approvals in the past 18 months.

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