3/28/2013

The FDA's abbreviated pathway for most biosimilars will not have a considerable effect on costs nor cause a significant change in the drug development landscape, writes Henry I. Miller, a former FDA biotechnology official. The high costs of planning, conducting and analyzing clinical trial 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.

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