"Human testing will not be an across-the-board requirement. "It depends on how confident you can be of the absolute sameness to the innovator product," Woodcock said. "There's a spectrum...some will get much closer than others in your ability to characterize them." "
THIS IS BIG. First time, I have heard that human testing of any kind is not mandatory ..Even Momenta was stating some clinical trial maybe needed on biologics.
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