US Biosimilar Biologics – The Ship has Sailed
- Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr.
- European Biotechnology News
In this European Biotechnology News IP Flash article Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr. provide an overview of recent activity related to biosimilar biologics at the U.S Food and Drug Administration and the Court of Appeals for the Federal Circuit. The duo highlights the recent success of generic biologic manufactures and asserts that "the era of generic biologic drugs has officially begun."
To read the full article, please download the attached PDF.