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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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Detalhes bibliográficos
Publicado no:Pharmaceutics
Main Authors: Gherghescu, Ioana, Delgado-Charro, M. Begoña
Formato: Artigo
Idioma:Inglês
Publicado em: MDPI 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7824407/
https://ncbi.nlm.nih.gov/pubmed/33396369
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3390/pharmaceutics13010048
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