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On the Regulatory Approval Pathway of Biosimilar Products

Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval fram...

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Detalles Bibliográficos
Main Authors: Jun Wang, Shein-Chung Chow
Formato: Artigo
Idioma:Inglês
Publicado: MDPI AG 2012-03-01
Series:Pharmaceuticals
Assuntos:
WHO
EMA
FDA
Acceso en liña:http://www.mdpi.com/1424-8247/5/4/353/
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