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...

Full description

Bibliographic Details
Main Authors: Ioana Gherghescu, M. Begoña Delgado-Charro
Format: Article
Language:English
Published: MDPI AG 2021-12-01
Series:Pharmaceutics
Subjects:
FDA
EMA
Online Access:https://www.mdpi.com/1999-4923/13/1/48