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Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

BACKGROUND: Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still...

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Detalles Bibliográficos
Autores principales: Sagi, Sreedhar, Anjaneya, Pradeep, Kalsekar, Sameer, Kottke, Andrea, Cohen, Hillel P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684613/
https://www.ncbi.nlm.nih.gov/pubmed/37902937
http://dx.doi.org/10.1007/s40264-023-01371-8