FDA Approves First Biosimilar in the U.S.

Posted on March 18, 2015 in: Medication Approvals

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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