Potential changes to the FDA approach to biosimilars have a global impact

Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):53-5.
DOI: 10.5639/gabij.2018.0702.011

Published in: Volume 7 / Year 2018 / Issue 2
Category: Commentary
Page: 53-5
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Visits: 2415 total, 2 today

Keywords: automatic substitution, FDA guidelines, global reference product, information, interchangeability, regulatory harmonization

The Opinion article of Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development. This article comments on some of the proposals from a global perspective, including the global reference product and the biosimilar comparability programme. FDA Commissioner Scott Gottlieb has stated that the biosimilar market suffers from a lack of competition. Therefore, the FDA approach to biosimilars, including many of the issues raised by Niazi will be revisited in the new Biosimilar Action Plan of the FDA.