- Pink Sheet
- >>Biosimilars
BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process
Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.
An expedited process for adding indications to biosimilar product labels and a staged review of 351(k) applications appear to be early items on industry’s wish list for the third iteration of the Biosimilar User Fee Act (BsUFA).
In comments to the US FDA on biologic product competition and innovation, Johnson & Johnson’s Janssen Pharmaceutical Cos. and Amgen Inc
