Titlebook: Biosimilars; A New Generation of Jean-Louis Prugnaud,Jean-Hugues Trouvin Book 2013 Springer-Verlag France 2013 Biomedicine.Biosimilars.Cos

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Jen Rinaldi,Andrea LaMarre,Carla Ricehis complexity’s consequence resides in the analytical techniques for the study of various structural aspects of the molecule population of interest. Powerful physico-chemical and biological methods have to be used in order to globally apprehend the molecules tridimensional integrity and ensure a th

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https://doi.org/10.1007/978-1-4842-5482-0adequate to evidence a biosimilar’s quality, safety and efficacy, due to the complexity of the products themselves but also of their production processes. The registration of biological products’ copies has been made possible by the creation of a specific regulatory framework by European regulatory

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Immunogenicity,ors influencing immunogenicity—structural, linked to impurities and other production contaminants, factors linked to the medicine’s formulation, or linked to patients and treatment dependant—are studied in that chapter, as well as their consequences in regulatory terms.

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Biosimilars: Challenges Raised by Biosimilars: Who is Responsible for Cost and Risk Management?,arket in value), payers’ (significant savings expected for all parties), at last doctors and pharmacists’. How costs are established, what savings may be expected, is there a liability specific to biosimilars? In this chapter, a quick comparative view of European and American approaches and the concept of interchangeability.