Biosimilars - BioRiver
Biosimilars - BioRiver
Biosimilars - BioRiver
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Questions for Discussion<br />
Structural Comparability<br />
• “How similar is similar ?” “Case by Case?”<br />
• FDA vs EMA Process – Harmonization – “Interchangeable” Discussion ?<br />
• CHO Genome public available and Product developments with e.g. glyco engineered Cell Lines<br />
How to achieve “Superimposable” Profile for these products?<br />
Economics<br />
• Dozens of Biosimilar candidates per blockbuster are on the way, while only few have reached clinical<br />
phase (EMA). Will similarity be an competitive advantage?<br />
• Will Biosimilar-Patents work out?<br />
• Will Asia play a similar role as in Generics ? Korea/India/China?<br />
(or When will it play this role?)<br />
Mindset<br />
Change from Innovation-Originator via Biobetter to Biosimilar in BigPharma !<br />
Need for Mindset change: “Biosimilar Development” differs from “NBE Development or Generics<br />
Development”. How can we speedup the process ?<br />
Regional<br />
• How can NRW position it self in the Biosimilar Landscape ?<br />
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