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Millennium Hotel & Convention Centre Kuwait

Nov 21, 2017 7:30 AM - Nov 22, 2017 5:30 PM

4th Ring Road, Salmiya, Abou Thar Al Ghafari St Safat , 13154 Kuwait, Kuwait City, 29370, Kuwait

DIA Middle East Regulatory Conference

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Session 6: Workshop 3 - Case Studies of Biosimilars

Session Chair(s)

Mai Allam

National Organization for Research & Control of Biologicals, Egypt

This sessions starts with a brief re-cap on how to assess biosimilar dossiers and the key steps in the development of these type of products. Thereafter, we will make it more concrete, by jointly reviewing some case examples of biosimilar applications. We will review the data packages of these ‘hypothetical cases’ and discuss whether or not the data presented is sufficient to conclude biosimilarity. If not, we will discuss what should be done differently, to be able to draw a conclusion on biosimilarity.

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