Biosimilars: Harmonizing the Approval Guidelines
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of th...
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| Autor principal: | |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
MDPI AG
2022-07-01
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| coleção: | Biologics |
| Assuntos: | |
| Acesso em linha: | https://www.mdpi.com/2673-8449/2/3/14 |
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