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.

journal_name

Pharmacol Res

journal_title

Pharmacological research

authors

Araújo FC,Gonçalves J,Fonseca JE

doi

10.1016/j.phrs.2019.104467

subject

Has Abstract

pub_date

2019-11-01 00:00:00

pages

104467

eissn

1043-6618

issn

1096-1186

pii

S1043-6618(19)31113-2

journal_volume

149

pub_type

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