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Pharmacological Research
Article . 2019 . Peer-reviewed
License: Elsevier TDM
Data sources: Crossref
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Biosimilars in rheumatology

Authors: Araújo, Filipe C.; Goncalves, Joao; Fonseca, João Eurico;

Biosimilars in rheumatology

Abstract

Biotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide. Since biosimilars are similar and more affordable versions of previously licenced biotechnologicals, they are expected to contribute to healthcare system sustainability and reduce inequities in treatment access. The landmark approval of CT-P13 as the first infliximab biosimilar paved the way for new infliximab but also etanercept, adalimumab and rituximab biosimilars. In Europe, North America and some countries of Asia, development is strictly regulated and only those presenting a totality-of-evidence dossier with highly similar physicochemical, biological and clinical performances are endorsed by regulatory agencies as biosimilars. The current article addresses the importance of biosimilar medicines in the treatment of IRD, as well as their innovative development and regulatory pathways, clinical evidence of similarity and challenges that may undermine their widespread use and success.

Keywords

Biosimilar, Adalimumab, Extrapolation, Antibodies, Monoclonal, Switch, Infliximab, Etanercept, Drug Development, Rheumatology, Antirheumatic Agents, Rheumatic Diseases, SB4, Animals, Humans, Rheumatic disease, Interchangeability, Rheumatic Fever, Rituximab, Biosimilar Pharmaceuticals, CT-P13

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    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    15
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
15
Top 10%
Average
Top 10%
gold