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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...
Uloženo v:
| Vydáno v: | J Diabetes Sci Technol |
|---|---|
| Hlavní autoři: | , |
| Médium: | Artigo |
| Jazyk: | Inglês |
| Vydáno: |
SAGE Publications
2014
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| Témata: | |
| On-line přístup: | 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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