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.
Posted by Tim Sandle
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