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An Integrated Approach for a Structural and Functional Evaluation of Biosimilars: Implications for Erythropoietin
BACKGROUND: Authorization to market a biosimilar product by the appropriate institutions is expected based on biosimilarity with its originator product. The analogy between the originator and its biosimilar(s) is assessed through safety, purity, and potency analyses. OBJECTIVE: In this study, we pro...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562010/ https://www.ncbi.nlm.nih.gov/pubmed/26334631 http://dx.doi.org/10.1007/s40259-015-0136-3 |