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Efficacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review

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Abstract

Objective

Regulatory approval of biosimilar versions of originator biotherapeutics requires that new biological products be highly similar to originator products, with no clinically meaningful differences in safety, purity, and potency. In some trials of biosimilars of tumor necrosis factor inhibitors for the treatment of rheumatoid arthritis (RA) and plaque psoriasis (PsO), pre-specified margins for efficacy and safety have been met, but differences in treatment responses between pivotal originator trials and biosimilar trials have been noted. The objective of this systematic review was to examine these differences.

Methods

Searches were conducted to identify comparative randomized clinical trials of approved or proposed biosimilars of adalimumab, etanercept, and infliximab.

Results

Of 83 publications identified, 16 publications were included for analysis (RA: originators, n = 5; biosimilars, n = 6; PsO: originators, n = 2; biosimilars, n = 3). American College of Rheumatology 20% response rates were higher among patients with RA receiving originator biologics and biosimilars in biosimilar trials than among patients receiving the originator biologics in pivotal trials. In etanercept studies in PsO, a difference was observed in Psoriasis Area and Severity Index 75% response rates between biosimilar and pivotal trials. Insufficient efficacy data were available from adalimumab and infliximab biosimilar studies in PsO to determine any differences in treatment responses between pivotal and biosimilar studies.

Conclusions

Observed differences in treatment response rates between pivotal originator trials and trials of originator biologics and their respective biosimilars may be attributable to fundamental differences in study design and/or baseline patient characteristics, which require further analysis.

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Author information

Authors and Affiliations

  1. University of Liverpool, Liverpool, UK

    Robert J. Moots

  2. Department of Musculoskeletal Biology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, Aintree University Hospital, Longmoor Lane, Liverpool, L9 7AL, UK

    Robert J. Moots

  3. Pfizer, Rome, Italy

    Cinzia Curiale

  4. Pfizer, Collegeville, PA, USA

    Danielle Petersel & Heather Jones

  5. Envision Pharma Group, Horsham, West Sussex, UK

    Catherine Rolland

  6. Organización Médica de Investigación, Buenos Aires, Argentina

    Eduardo Mysler

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  1. Robert J. Moots
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  2. Cinzia Curiale
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  4. Catherine Rolland
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  5. Heather Jones
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  6. Eduardo Mysler
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Contributions

All authors contributed to the development of the systematic literature review that forms the basis of this manuscript, were involved in drafting the manuscript and revising it critically for important intellectual content, and approved the final version for publication. All authors are accountable for all aspects of the work. RJM is the guarantor for the overall content.

Corresponding author

Correspondence to Robert J. Moots.

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Funding

This article was funded by Pfizer. The literature search was conducted by Catherine Rolland, PhD, and Eva Scholtus, MSc, of Envision Pharma Group, and was funded by Pfizer. Medical writing support was provided by Lorna Forse, PhD, and Rina Vekaria Passmore, PhD, of Engage Scientific Solutions, and was funded by Pfizer.

Conflict of interest

Robert J. Moots has received research grants from AKL Pharmaceuticals, UCB Pharma, Novartis, and Pfizer; consulting fees from Chugai, Novartis, Pfizer, Roche, and Sandoz; support for travel to meetings where presenting research from Chugai, Novartis, Pfizer, Roche, and Sandoz; provision of writing assistance from Engage Scientific Solutions; and payment for lectures including service on speakers bureaus from Chugai, Pfizer, and Roche. Catherine Rolland is an employee of Envision Pharma Group and was a paid consultant to Pfizer in connection with the development of this manuscript. Eduardo Mysler has no conflicts to declare. Cinzia Curiale, Danielle Petersel, and Heather Jones are employees of and hold stock in Pfizer.

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Moots, R.J., Curiale, C., Petersel, D. et al. Efficacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review. BioDrugs 32, 193–199 (2018). https://doi.org/10.1007/s40259-018-0283-4

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  • DOI: https://doi.org/10.1007/s40259-018-0283-4

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