Biosimilars for psoriasis: clinical studies to determine similarity

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art_BLAUVELT_Biosimilars_for_psoriasis_clinical_studies_to_determine_similarity_2017.PDF (209.96 KB)
Citações na Scopus
17
Tipo de produção
article
Data de publicação
2017
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
WILEY
Autores
BLAUVELT, A.
PUIG, L.
CHIMENTI, S.
VENDER, R.
RAJAGOPALAN, M.
SKOV, L.
ZACHARIAE, C.
YOUNG, H.
PRENS, E.
Citação
BRITISH JOURNAL OF DERMATOLOGY, v.177, n.1, p.23-33, 2017
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.
Palavras-chave
URI
https://observatorio.fm.usp.br/handle/OPI/21509
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Coleções
Artigos e Materiais de Revistas Científicas - HC/ICHC