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

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