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Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

BACKGROUND: Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many prescribers still have doubts on the safety and interch...

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Detalles Bibliográficos
Autores principales: Kurki, Pekka, Barry, Sean, Bourges, Ingrid, Tsantili, Panagiota, Wolff-Holz, Elena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8578115/
https://www.ncbi.nlm.nih.gov/pubmed/34596876
http://dx.doi.org/10.1007/s40265-021-01601-2