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FDA Approves First Biosimilar in the U.S.
Posted on March 18, 2015
On March 6, 2015, the U.S. Food and Drug Administration (FDA) announced the approval of Zarxio
®
(filgrastim-sndz) as a biosimilar to Neupogen
®
. The formulation of Zarxio differs from that of U.S.-licensed Neupogen in one inactive component, and a review of evidence demonstrated that “there are no clinically meaningful differences between Zarxio and U.S.-licensed Neupogen,” according to an
FDA announcement
. In addition, the agency notes that more biosimilar treatment options are expected to be approved in the future.
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FDA Advisory Panel Votes for Approval of First U.S. Biosimilar
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