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The European Union regulatory standard for designation of biosimilarity requires a suitable weight of evidence, determined on a product-specific basis, to demonstrate that the immunogenicity associated with the biosimilar product does not lead to a higher negative impact on clinically relevant outcomes compared with the reference product.
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This test was applied in the 2002 Winter Games in Salt Lake, where three athletes were caught with darbepoetin alfa in their urine samples and they were sanctioned ().
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When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD).
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Pharma biologics, 3 Sandoz biosimilars and 1 Alcon product) and 50-60 more expected to come through from NIBR.
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As has already been stated, available prices of hospital medicines are not very reliable, as they are often subject to discounts, rebates and other confidential price reductions, which might distort the results of the analysis.
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Usually, the shipments are delivered within 5-17 days but in some cases there may be a delay for 5 more days.
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The manufacturer of the trastuzumab originator product had abandoned its patent for the innovator, purportedly in response to anticipated governmental issuance of a compulsory licence for trastuzumab because of inaffordability.
Biosimilars in the EU are usually priced 15 percent to 30 percent below their referenced products, but they have achieved little market share because of their lack of interchangeability.
In February 2012, the FDA issued preliminary guidelines for biosimilar entry, which will be available for comment for 60 days.
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