Abstract
This chapter is specifically dedicated to the characteristics of potentially immunogenic proteins. Biosimilars face that risk. Immune mechanisms, factors 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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Prugnaud, JL. (2013). Immunogenicity. In: Prugnaud, JL., Trouvin, JH. (eds) Biosimilars. Springer, Paris. https://doi.org/10.1007/978-2-8178-0336-4_3
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DOI: https://doi.org/10.1007/978-2-8178-0336-4_3
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