FDA View On Amarin Disclosures Undercuts 'Same Labeling' For Biosimilars

FDA View On Amarin Disclosures Undercuts 'Same Labeling' For Biosimilars – AbbVie

19 Aug 2015

Decision to require labeling for Zarxio that is identical to its reference product cannot be squared with agency's representation in the Vascepa off-label promotion lawsuit that failure to expressly disclose when studies were conducted using other products is misleading, petition says.

FDA statements in recent litigation with Amarin Corp. PLC involving off-label promotion undercut the agency's decision to apply a generic-like labeling approach to the first biosimilar approval, AbbVie Inc. says.

The agency's view that it would be misleading for Amarin not to disclose whether certain studies that it sought to...