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

Category: Commentary
Author(s):
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Keywords: Automatic substitution, biosimilars, FDA guidelines, global reference product, interchangeability, regulatory harmonisation
Abstract:
The paper of Niazi in this issue of GaBI Journal argues that the FDA could make several adjustments to its guidance in order to facilitate the development of biosimilars [1]. The Author points out that the current requirements have led to high costs and long development times which discourage small and medium-sized enterprises from entering biosimilar development. Indeed, FDA Commissioner Scott Gottlieb has stated that the biosimilar market suffers from a lack of competition [2, 3]. Some of the proposals of the author deserve comments from a global perspective.

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