The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US
By Zachary Brennan -
Published 05 September 2017
Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.
Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs
Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars