Vladimir Hanes of Amgen's 2015 Presentation is now available for download.
At last year's World Biosimilar Congress USA, we were excited to have Vladimir Hanes, Medical Director of Oncology/Biosimilars at Amgen, share his expertise on the structure, function, and the science of biosimilarity in designing meaningful biosimilar development programs.
You can now download his presentation to find out more about:
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FDA & EU definitions of biosimilars
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Generics and biosimilars
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The biotechnology manufacturing process
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Development steps and residual uncertainty
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Cell-line and process case studies
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How PK results demonstrate bioequivalence