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Drug Development and Potential Regulatory Paths for Insulin Biosimilars
Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. Biosimilar insulins have the potential to reduce ever gro...
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| Pubblicato in: | J Diabetes Sci Technol |
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| Autori principali: | , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
SAGE Publications
2014
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4454099/ https://ncbi.nlm.nih.gov/pubmed/24876531 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1932296813516954 |
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