The FDA's abbreviated pathway for most biosimilars will not have a considerable effect on costs nor cause a major change in the drug development landscape, writes Henry I. Miller, a former FDA biotechnology official. The high costs of planning and conducting clinical trials and analyzing the results will inhibit the rush to produce biosimilars. Each biosimilar has to be considered effectively as a novel treatment, making for a much more expensive process than the development of small-molecule generics.
Former FDA official: Biosimilar pathway won't bring a revolution
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