Reject AbbVie 'Interchangeable' Petition, Sandoz Tells FDA
This article was originally published in Scrip
Executive Summary
The FDA should reject in its entirety AbbVie Inc.'s citizen petition calling for certain measures to be met before the agency licenses a biosimilar as interchangeable because the rationale and data on which the company based its request are "limited, misrepresented and misleading," argued Novartis AG unit Sandoz Inc.