FDA Admits It Has Yet To Fill In Big Gaps On Biosimilar Regs

Law360, New York (August 8, 2012, 7:55 PM EDT) -- The U.S. Food and Drug Administration sketched new details Wednesday on how biosimilar medicines can win approval, but said it's yet to decide some of the industry's biggest questions, including how the treatments can be deemed interchangeable with brand-name counterparts.

The revelations of slower-than-hoped progress emerged during an FDA advisory committee hearing and were described as resulting from caution on a new pharmaceutical frontier. Agency officials offered few insights as to when clarity would be available.

“There are some things that have not yet been dealt...
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