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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...

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Detalles Bibliográficos
Autor principal: Hus, Iwona
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Termedia Publishing House 2013
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