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Adalimumab biosimilars in Europe: an overview of the clinical evidence

Adalimumab biosimilars in Europe: an overview of the clinical evidence
Adalimumab biosimilars in Europe: an overview of the clinical evidence

Adalimumab, the first fully humanised monoclonal antibody against tumour necrosis factor alpha (TNF-α), has played a leading role in the revolution brought about by the introduction of biologics, and has received the widest range of indications among TNF-α inhibitors. Post-registration, observational and registry studies of real-life use have largely supported the outcomes seen in registrational clinical trials. With the recent loss of exclusivity for the originator medicinal product in Europe, a number of biosimilar adalimumab molecules have been licensed for use in the same indications as the originator molecule across rheumatology, dermatology, gastroenterology and ophthalmology. Clinicians in these areas first gained experience with biosimilar infliximab, followed by etanercept and rituximab. However, adalimumab is likely to present unique challenges given the numbers of patients treated and the range of biosimilar adalimumab products available. The biosimilar approval pathway has an emphasis on the pre-clinical analytic data in combination with clinical studies conducted to confirm therapeutic equivalence. To date, several adalimumab biosimilars have entered the EU market following successful marketing authorisation applications and recent expiration of originator patent protection. This overview covers the extent of use of adalimumab and summarises the regulatory process involved in the development of biosimilars as well as their use in clinical practice. The authors also discuss clinical data available so far on adalimumab biosimilars and their envisaged impact in the field of immune-mediated inflammatory diseases.

1173-8804
Bellinvia, Salvatore
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Cummings, J. R.Fraser
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Ardern-Jones, Michael R.
7ac43c24-94ab-4d19-ba69-afaa546bec90
Edwards, Christopher J.
dcb27fec-75ea-4575-a844-3588bcf14106
Bellinvia, Salvatore
35fd7d0a-d262-4f0d-89dc-76cc5b0cbf8d
Cummings, J. R.Fraser
89e8e80c-b6e8-4387-a63c-3796b5ad7e14
Ardern-Jones, Michael R.
7ac43c24-94ab-4d19-ba69-afaa546bec90
Edwards, Christopher J.
dcb27fec-75ea-4575-a844-3588bcf14106

Bellinvia, Salvatore, Cummings, J. R.Fraser, Ardern-Jones, Michael R. and Edwards, Christopher J. (2019) Adalimumab biosimilars in Europe: an overview of the clinical evidence. BioDrugs. (doi:10.1007/s40259-019-00355-4).

Record type: Article

Abstract

Adalimumab, the first fully humanised monoclonal antibody against tumour necrosis factor alpha (TNF-α), has played a leading role in the revolution brought about by the introduction of biologics, and has received the widest range of indications among TNF-α inhibitors. Post-registration, observational and registry studies of real-life use have largely supported the outcomes seen in registrational clinical trials. With the recent loss of exclusivity for the originator medicinal product in Europe, a number of biosimilar adalimumab molecules have been licensed for use in the same indications as the originator molecule across rheumatology, dermatology, gastroenterology and ophthalmology. Clinicians in these areas first gained experience with biosimilar infliximab, followed by etanercept and rituximab. However, adalimumab is likely to present unique challenges given the numbers of patients treated and the range of biosimilar adalimumab products available. The biosimilar approval pathway has an emphasis on the pre-clinical analytic data in combination with clinical studies conducted to confirm therapeutic equivalence. To date, several adalimumab biosimilars have entered the EU market following successful marketing authorisation applications and recent expiration of originator patent protection. This overview covers the extent of use of adalimumab and summarises the regulatory process involved in the development of biosimilars as well as their use in clinical practice. The authors also discuss clinical data available so far on adalimumab biosimilars and their envisaged impact in the field of immune-mediated inflammatory diseases.

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Adalimumab biosimilar final draft for submission - Accepted Manuscript
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Accepted/In Press date: 8 May 2019
e-pub ahead of print date: 20 May 2019

Identifiers

Local EPrints ID: 432023
URI: http://eprints.soton.ac.uk/id/eprint/432023
ISSN: 1173-8804
PURE UUID: a377bdc9-d318-4ca8-8346-5af6235555e9

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Date deposited: 26 Jun 2019 16:30
Last modified: 26 Nov 2021 05:03

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Contributors

Author: Salvatore Bellinvia
Author: J. R.Fraser Cummings

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