Biosimilars - BioRiver

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Evaluation of Comparability: Marketed Product • How to handle the change of the quality profile of an originator during development of a biosimilar? Quality specifications Time Begin of Development Originator Safety and efficacy have to be similar Still similar? � Quality range for comparability Biosimilar Marketing Authorization Similar through lifecycle? Concept published by Mark Mc Camish and Gillian Woolett mABs 3:2, 209-217, March/April 2011 © Landes Bioscience - 18 -
Questions for Discussion Structural Comparability • “How similar is similar ?” “Case by Case?” • FDA vs EMA Process – Harmonization – “Interchangeable” Discussion ? • CHO Genome public available and Product developments with e.g. glyco engineered Cell Lines How to achieve “Superimposable” Profile for these products? Economics • Dozens of Biosimilar candidates per blockbuster are on the way, while only few have reached clinical phase (EMA). Will similarity be an competitive advantage? • Will Biosimilar-Patents work out? • Will Asia play a similar role as in Generics ? Korea/India/China? (or When will it play this role?) Mindset Change from Innovation-Originator via Biobetter to Biosimilar in BigPharma ! Need for Mindset change: “Biosimilar Development” differs from “NBE Development or Generics Development”. How can we speedup the process ? Regional • How can NRW position it self in the Biosimilar Landscape ? - 19 -
Page 1 and 2: Comprehensive structural and physic
Page 3 and 4: Protagen AG - Facts and Location Pr
Page 5 and 6: Protagen AG - Spectrum of Analytica
Page 7 and 8: Agenda • Introduction to Protagen
Page 9 and 10: Biosimilar Definition “A biosimil
Page 11 and 12: What are Biosimilars? Biosimilars s
Page 13 and 14: Best Practice Comparability Study -
Page 15 and 16: Evaluation of Comparability: Not a
Page 17: Evaluation of Comparability: Market

Biosimilars - BioRiver

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