Naming of biosimilars a confidence game on a deadline
With the FDA expected to approve its first biosimilar within a year or two, how to name the follow-on biologics has passed from an academic debate to a must-do proposition. Since sponsors must include the name in the dossier when they submit a biosimilar application, those that are getting close to filing need to know pretty quickly how the drugs are to be named, Sumant Ramachandra, senior vice president and chief scientific officer at Hospira Inc., told BioWorld Today.
Suite: 1100 | Atlanta, Georgia 30346, USA
Outside of the US
In the U.S. and Canada: +1-800-336-4474
Outside the U.S.: +44-203-684-1796
Hours: Monday - Friday, 8:00am - 6:00 pm EST
Sign up for Highlights FREE e-mail newsletter