Biosimilar Interchangeability Stymied Mainly By Extrapolation Uncertainties, Amgen Says
This article was originally published in The Pink Sheet Daily
Amgen’s R&D head Miletich tells the BIO International Convention that understanding, not detecting, minor structural differences between products is a key hurdle to creating interchangeable biologics. Also, designing trials which satisfy the statute’s “any given patient” requirement is daunting.
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