Biosimilars - BioRiver

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Protein Analytical Services Therapeutic proteins successfully analyzed in-house are: • NBE, eg. Antibodies • Recombinant monoclonal IgG-Type • Polyclonal IgG • Fusion Proteins • Fc-constructs • Fab-fragments • Marketed Biopharmaceuticals, e.g. Originator Active Ingredient Analyzed by Protagen AG Avastin Bevacizumab Innovator Betaseron Interferon beta-1b Biosimilar Copaxone Glatiramer acetate Biosimilar Enbrel Etanercept Innovator, Biosimilar Epogen, Eprex Erythropoietin Innovator, Biosimilar Erbitux Cetuximab Innovator Herceptin Trastuzumab Innovator Humira Adalimumab Innovator, Biosimilar Hirudin Innovator Neupogen Filgrastim Innovator, Biosimilar Nutropin Somatropin Biosimilar Remicade Infliximab Innovator, Biosimilar Rituxan Rituximab Innovator, Biosimilar Tysabri Natalizumab Innovator - 6 -
Agenda • Introduction to Protagen AG • Biosimilar Comparability - 7 -
Page 1 and 2: Comprehensive structural and physic
Page 3 and 4: Protagen AG - Facts and Location Pr
Page 5: Protagen AG - Spectrum of Analytica
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 and 18: Evaluation of Comparability: Market
Page 19 and 20: Questions for Discussion Structural

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