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

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

Abstract: 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 […]

Read more →