FDA News

 

Blow to Pipelines: Interchangeability Likely to Require Clinical Data

The FDA appears poised to require clinical trial data from drugmakers seeking interchangeability designations for biosimilars, a move that could shrink the number of products aiming to achieve the standard, drugmakers and legal experts say.


300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.