Public Health Impact of Using Biosimilars, Is Automated Follow up Relevant?

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Public Health Impact of Using Biosimilars, Is Automated Follow up Relevant?

Int Journal of Environmental Research and Public Health

Fecha de publicación: 29 de Diciembre de 2020

DOI: 10.3390/ijerph18010186

Autores: Antoine Perpoil, Gael Grimandi, Stéphane Birklé, Jean-François Simonet, Anne Chiffoleau, François Bocquet

Abstract: Biologic reference drugs and their copies, biosimilars, have a complex structure. Biosimilars need to demonstrate their biosimilarity during development but unpredictable variations can remain, such as micro-heterogeneity. The healthcare community may raise questions regarding the clinical outcomes induced by this micro-heterogeneity. Indeed, unwanted immune reactions may be induced for numerous reasons, including product variations. However, it is challenging to assess these unwanted immune reactions because of the multiplicity of causes and potential delays before any reaction. Moreover, safety assessments as part of preclinical studies and clinical trials may be of limited value with respect to immunogenicity assessments because they are performed on a standardised population during a limited period.

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