Sunday, 15 February 2015

FDA Recommends Approval of First Biosimilar Application

According to BioPharm International, an FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.

FDA's Oncologic Drugs Advisory Committee met on Jan. 7, 2015 to review the Biologics License Application (BLA) submitted by Sandoz for a biosimilar version of Amgen's Neupogen (filgrastim). In the meeting, regulators concluded that there were no clinically meaningful differences between Amgen’s Neupogen (filgrastim) and Sandoz’s follow-on biologic version (EP2006) and recommended the agency approve the product. Sandoz already confirmed similarity of their version of filgrastim compared with reference product Neupogen in terms of safety and efficacy in late 2014.

For further details, see BioPharm.

Posted by Tim Sandle