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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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Bibliographic Details
Published in:Pharmaceutics
Main Authors: Gherghescu, Ioana, Delgado-Charro, M. Begoña
Format: Artigo
Language:Inglês
Published: MDPI 2020
Subjects:
Online Access: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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