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Biosimilar Interchangeability Stymied Mainly By Extrapolation Uncertainties, Amgen Says

This article was originally published in The Pink Sheet Daily

Executive Summary

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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