US FDA lays out its position on generic Lovenox as observers ask, is Copaxone next?
This article was originally published in Scrip
Executive Summary
One issue connected to the 23 July US approval of Sandoz's generic version of Sanofi-Aventis's antithrombotic, Lovenox (enoxaparin sodium), continues to astonish some outside the US: that the FDA sees the product as a candidate for approval via the generic pathway, while the EU authorities view the low molecular-weight heparin (LMWH) as a biosimilar drug requiring clinical trials for approval.