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Follow-on biologics in oncology – the need for global and local regulations
The patent expiration for first-generation biological drugs has prompted the development of a new group of biopharmaceuticals – follow-on biologics. The extent of studies needed in the process of follow-on biologics approval is incomparably greater than in the case of generics but reduced in compari...
Autor principal: | Hus, Iwona |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Termedia Publishing House
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3687471/ https://www.ncbi.nlm.nih.gov/pubmed/23788931 http://dx.doi.org/10.5114/wo.2012.32475 |
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