Biosimilars for psoriasis: clinical studies to determine similarity

Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine biosimilarity. In this review writt...

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मुख्य लेखकों: Andrew Blauvelt, L. Puig, Sergio Chimenti, Ronald Vender, Murlidhar Rajagopalan, Ricardo Romiti, Lone Skov, Claus Zachariae, Helen Young, Errol P. Prens, Arnon D. Cohen, J. van der Walt, Jashin J. Wu
स्वरूप: Revisão
भाषा:अंग्रेज़ी
प्रकाशित: 2016
ऑनलाइन पहुंच:https://doi.org/10.1111/bjd.15067
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access_facet Acesso Aberto
author Andrew Blauvelt
L. Puig
Sergio Chimenti
Ronald Vender
Murlidhar Rajagopalan
Ricardo Romiti
Lone Skov
Claus Zachariae
Helen Young
Errol P. Prens
Arnon D. Cohen
J. van der Walt
Jashin J. Wu
author_facet Andrew Blauvelt
L. Puig
Sergio Chimenti
Ronald Vender
Murlidhar Rajagopalan
Ricardo Romiti
Lone Skov
Claus Zachariae
Helen Young
Errol P. Prens
Arnon D. Cohen
J. van der Walt
Jashin J. Wu
cited_by_count_is 19
collection OpenAlex
description Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine 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. This article is protected by copyright. All rights reserved.
format Revisão
frbr_group_id_str doi-10.1111/bjd.15067
id openalex-W2519779602
institution Oregon Medical Research Center
issn_str 0007-0963
issue_str 1
journal_title_str British Journal of Dermatology
language eng
publishDate 2016
publisher_str Oxford University Press
spellingShingle Biosimilars for psoriasis: clinical studies to determine similarity
Andrew Blauvelt
L. Puig
Sergio Chimenti
Ronald Vender
Murlidhar Rajagopalan
Ricardo Romiti
Lone Skov
Claus Zachariae
Helen Young
Errol P. Prens
Arnon D. Cohen
J. van der Walt
Jashin J. Wu
title Biosimilars for psoriasis: clinical studies to determine similarity
title_full Biosimilars for psoriasis: clinical studies to determine similarity
title_fullStr Biosimilars for psoriasis: clinical studies to determine similarity
title_full_unstemmed Biosimilars for psoriasis: clinical studies to determine similarity
title_short Biosimilars for psoriasis: clinical studies to determine similarity
topic_facet Biosimilar
Psoriasis
Similarity (geometry)
Medicine
Dermatology
MEDLINE
Intensive care medicine
Computer science
Internal medicine
Artificial intelligence
Chemistry
Image (mathematics)
Biochemistry
url https://doi.org/10.1111/bjd.15067
volume_str 177