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

Category: Commentary
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Keywords: Automatic substitution, biosimilars, FDA guidelines, global reference product, interchangeability, regulatory harmonisation
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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