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The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents
A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is “highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and...
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| Format: | Artigo |
| Langue: | Inglês |
| Publié: |
American Society of Nephrology
2014
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| Accès en ligne: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4152809/ https://ncbi.nlm.nih.gov/pubmed/24970875 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2215/CJN.01770214 |
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