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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicine...

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Detalles Bibliográficos
Autores principales: Gherghescu, Ioana, Delgado-Charro, M. Begoña
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824407/
https://www.ncbi.nlm.nih.gov/pubmed/33396369
http://dx.doi.org/10.3390/pharmaceutics13010048