Biosimilars: The Need, The Challenge, The Future: The FDA Perspective

@article{Epstein2014BiosimilarsTN,
  title={Biosimilars: The Need, The Challenge, The Future: The FDA Perspective},
  author={Michael S. Epstein and Eli Daniel Ehrenpreis and Prasad M. Kulkarni},
  journal={The American Journal of Gastroenterology},
  year={2014},
  volume={109},
  pages={1856-1859}
}
OBJECTIVES:This article summarizes the brief history of the biosimilars industry, the FDA's regulations and guidance for biosimilars development, and the issues and challenges facing developers and regulators in bringing biosimilars to market.METHODS:Current literature, regulations, and FDA guidance documents were summarized and interpreted to define biosimilars and to present their financial and clinical implications.RESULTS:Some biologic agents that will lose patent protection during the next… CONTINUE READING
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