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Biosimilars in rheumatology: the wind of change

Schneider, Christian K

Annals of the rheumatic diseases, 2013-03, Vol.72 (3), p.315-318 [Periódico revisado por pares]

England: BMJ Publishing Group Ltd and European League Against Rheumatism

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  • Título:
    Biosimilars in rheumatology: the wind of change
  • Autor: Schneider, Christian K
  • Assuntos: Anti-TNF ; Biological products ; Biosimilar Pharmaceuticals - pharmacokinetics ; Biosimilar Pharmaceuticals - standards ; DMARDs (biologic) ; Growth hormones ; Humans ; Licenses ; Manufacturing ; Medicine ; Pharmaceutical industry ; Rheumatology ; Rheumatology - trends ; Therapeutic Equivalency ; Treatment
  • É parte de: Annals of the rheumatic diseases, 2013-03, Vol.72 (3), p.315-318
  • Notas: istex:DA9D6AD3583CD7DF284225DD519315EFAF3F3561
    Related-article-href:10.1136/annrheumdis-2012-202715
    ArticleID:annrheumdis-2012-202941
    href:annrheumdis-72-315.pdf
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    local:annrheumdis;72/3/315
    ark:/67375/NVC-MKVKH734-T
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    ObjectType-Editorial-2
    ObjectType-Commentary-1
  • Descrição: A recent publication suggested that licensed biologics undergo changes in relevant molecular attributes over time. 10 In fact, the seminal regulatory guideline ICH Q5E, issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 11 an internationally agreed standard that sets the data requirements for changes to the manufacturing process for biotechnological and biological products, stipulates that "The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change product are identical, but that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product". [...]all of the licensed mAbs and -cept fusion proteins used in rheumatology have had changes in their manufacturing processes after their initial approval ( figure 1 A).
  • Editor: England: BMJ Publishing Group Ltd and European League Against Rheumatism
  • Idioma: Inglês
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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