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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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Detalhes bibliográficos
Main Authors: Wang, Jun, Chow, Shein-Chung
Formato: Artigo
Idioma:Inglês
Publicado em: MDPI 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3763644/
https://ncbi.nlm.nih.gov/pubmed/24281406
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3390/ph5040353
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