GOP Senators Request FDA Clarification of Biosimilars Policy

Thursday, May 7, 2015

Source: FDA News

Republicans on the Senate HELP Committee are taking the FDA to task for failing to shore up policies on biosimilar naming and interchangeability before approving the first biosimilar drug nearly two months ago.

Sandoz made history in March when the FDA approved Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen (filgrastim) chemotherapy drug. Though the drug has a unique name, the FDA made clear at the time that the name was just a placeholder and that it would decide later whether biosimilars should get unique names or use international nonproprietary names.

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