ARTICLE | Regulation

Equivalence test case

Lessons from FDA approval of generic version of sanofi-aventis' Lovenox

August 2, 2010 7:00 AM UTC

While FDA's response to a Citizen's Petition lodged by sanofi-aventis Group specifically addresses the requirements for demonstrating the equivalence of enoxaparin products, it sheds light on the technical rigor that is likely to be necessary for approval of copies of other complex molecules, including biologics.

The document was released on July 23, the same day FDA approved the first ANDA for a generic enoxaparin, which was developed by Momenta Pharmaceuticals Inc. and Sandoz Inc., the generics unit of Novartis AG...