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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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Dades bibliogràfiques
Publicat a:Pharmaceutics
Autors principals: Gherghescu, Ioana, Delgado-Charro, M. Begoña
Format: Artigo
Idioma:Inglês
Publicat: MDPI 2020
Matèries:
Accés en línia: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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