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Strengths and weaknesses of the Brazilian regulation on biosimilars: A critical view of the regulatory requirements for biosimilars in Brazil

Biological products or biopharmaceuticals are medicinal products derived from living systems and manufactured by modern biotechnological methods that differ widely from the traditional synthetic drugs. Monoclonal antibodies are the most rapidly growing type of biologic. They are much larger and more...

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Detalles Bibliográficos
Autores principales: de Assis, Marcos Renato, Pinto, Valdair
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6262503/
https://www.ncbi.nlm.nih.gov/pubmed/30515251
http://dx.doi.org/10.1177/1759720X18809683