Biosimilars - BioRiver

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Benefit on Early Detailed Characterization […] a reduction in the data requirements is possible for biosimilars, the prelicensing data package is nevertheless substantial. Similarity in physicochemical characteristics is a prerequisite for a possible reduction in nonclinical and clinical data requirements. The amount of possible data reduction depends on how well the molecule can be characterized by state-of-the-art analytical methods, on observed or potential differences between the biosimilar and the reference product, and the clinical experience gained with the reference product and/or the substance class […]. Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) of the Committee for Medicinal Products for Human Use (CHMP), EMA Martina Weise et al. Nature Biotechnology 29 (8) August 2011
Best Practice Comparability Study - Binocrit „Superimposable quality characteristics were demonstrated for a ‘biosimilar’ epoetin.“ [1] CZE MALDI IEF [1] Nature Biotechnology 29 (8) August 2011 [2] EJHPPractice 15 2009/2; C Brockmeyer and A Seidel, Sandoz
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: What are Biosimilars? Biosimilars s
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

Biosimilars - BioRiver

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