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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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Detaylı Bibliyografya
Yayımlandı:Pharmaceutics
Asıl Yazarlar: Gherghescu, Ioana, Delgado-Charro, M. Begoña
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: MDPI 2020
Konular:
Online Erişim: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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