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The approval of Omnitrope was based on demonstration of equivalent efficacy and safety, including immunogenicity, in the most sensitive population, namely treatment-naïve growth hormone-deficient children.
This guideline meets NGC's 2013 (revised) inclusion criteria.
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Even in the case that a similar host cell line were used, it is possible that there could be detectable differences in levels of the potentially nonhuman antigenic glycan, N-glycolyl neuraminic acid (Neu5Gc), that could result in an altered propensity for binding to pre-existing antibodies in human subjects.
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