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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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| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
MDPI
2012
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| Schlagworte: | |
| Online Zugang: | 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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