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If a nonclinical immunogenicity evaluation were performed, the primary purpose would be to enable a valid interpretation of the nonclinical findings, rather than to predict immunogenic potential in humans.
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These copied biopharmaceutical including IFNs, G-CSF and GH have received marketing authorization for the local Iranian market, but none have received evaluation according to internationally recognized guidelines for biosimilars.
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The impact of immunogenicity-related risks on overall benefit and risk is also considered in relation to extrapolation to therapeutic indications not studied in the preauthorization phase, as well as interchangeability of biosimilar and innovator versions.
An important distinction between biosimilars and their small-molecule counterparts, generics, is that biosimilars are not necessarily therapeutically equivalent to the reference product.
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As of last year, the biosimilar was in Phase II trials in Argentina, Austria, Brazil, France, Germany, India, Italy, Spain, and Turkey.
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Given the high costs of development and manufacturing, prices are unlikely to decrease by 80% or 90%, as was observed in the generics market.
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Experience of reviewing the follow-on biologics including somatropin and erythropoietin in Japan.
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Studies evaluating the use of erythropoietin-stimulating agents (ESAs) were included if given to treat cancer treatment-induced anaemia.
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Readers with questions regarding guideline content are directed to contact the guideline developer.
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MAA for its proposed biosimilar of Neulasta (pegfilgrastim).
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However, in performing our evaluation, we also consider equivalent measures of performance which are not affected by changes in the relative value of currencies.
T-helper cell stimulation for biosimilar candidates that meet the EU standard of structural comparability, ie, 100% identical primary amino acid sequence and a highly similar post-translational modification profile.
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For most biologicals in Japan, both the reference biological and the biosimilar non-proprietary name must bear a suffix to the non-proprietary name to distinguish the product.
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Data extraction for these studies was checked by a second reviewer.
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