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Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence

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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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Authors and Affiliations

  1. Department of Rheumatology and NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK

    Salvatore Bellinvia & Christopher J. Edwards

  2. Department of Rheumatology, Salisbury NHS Foundation Trust, Salisbury, UK

    Salvatore Bellinvia

  3. Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK

    J. R. Fraser Cummings

  4. Clinical Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK

    J. R. Fraser Cummings & Michael R. Ardern-Jones

  5. Department of Dermatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK

    Michael R. Ardern-Jones

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  3. Michael R. Ardern-Jones
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  4. Christopher J. Edwards
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Correspondence to Christopher J. Edwards.

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No sources of funding were used to prepare this manuscript.

Conflicts of Interest

MAJ has acted as an investigator for an AbbVie commercial clinical study (unpaid); CJE has received honoraria for advisory boards and speakers bureaus and research support from AbbVie, BMS, Biogen, Celgene, Fresnius, Janssen, Eli Lilly, Mundipharma, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sanofi and UCB; JRFC has received either research support, speakers fees, consulting fees or other support from AbbVie, Amgen, Astra Zeneca, Biogen, Celltrion, GSK, Janssen, Pfizer, MSD, Samsung Bioepis, Sandoz, Takeda; SB has no conflicts of interest to report.

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Bellinvia, S., Cummings, J.R.F., Ardern-Jones, M.R. et al. Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence. BioDrugs 33, 241–253 (2019). https://doi.org/10.1007/s40259-019-00355-4

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