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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Main Authors: Jun Wang (Author), Shein-Chung Chow (Author)
Formato: Libro
Publicado: MDPI AG, 2012-03-01T00:00:00Z.
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