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CONCLUSIONS: In patients with 1b HCV-related chronic hepatitis who develop anemia during antiviral treatment, administration of epoetin alpha increases hemoglobin levels and the end-of-treatment rate and sustains virological response by improving treatment adherence.

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This figure confirms several points: (1) batch to batch variability is small during routine manufacturing, (2) major shifts in product attributes may occur as a result of manufacturing changes, (3) in this case EU and US products are “highly similar” and are probably manufactured in the same plant, (4) the variance induced by manufacturing changes establishes “goal posts” that a biosimilar company can employ for establishing comparability and (5) it is apparent that originators are essentially manufacturing biosimilars of their original product.

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For instance, the European packaging for Zarzio (the European trade name for Zarxio) identifies the product by that trade name and by its International Nonproprietary Names name, filgrastim.

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Several methods have been used to financially incentivize stakeholders to utilize lower priced biosimilars, leading to increases in biosimilars uptake.

If originators can prepare global data sets and dossiers, but biosimilar sponsors cannot, this will have a major impact on the supply of the respective products, and the consequent access by patients.

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IGES Institute, The competitive role of biosimilars in the German SHI market for pharmaceuticals, 2010.

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Development also includes an expense due to an adjustment of a contingent consideration; Other income also includes gains from product divestments; Other income and Other expense also include net legal settlements.

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