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THERAPY IN 2019

Overcoming barriers to biosimilars in inflammatory arthritis

The availability of biosimilars to treat inflammatory diseases has generated concern about changing patients from a bio-originator to its biosimilar to save costs. Studies published in 2019 support the effectiveness and safety of ‘nonmedical switching’ and highlight the benefits of communicating information about biosimilars to patients in a positive light.

Key advances

  • The safety and efficacy of switching from infliximab to the infliximab biosimilar CT-P13 is similar to continued treatment with either infliximab or the biosimilar4.

  • Disease activity and flare rates do not differ between the 3 months immediately before and the 3 months immediately after ‘nonmedical switching’ from etanercept to the etanercept biosimilar SB4 (ref.5).

  • Presenting information about biosimilars to patients in a positive light increases patient acceptance of the biosimilar and might improve persistence of treatment with the biosimilar6.

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Fig. 1: Pathway for successful incorporation of biosimilars into clinical practice.

References

  1. European Medicines Agency. Centrally authorised biosimilar medicines. EMA https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine/field_ema_med_status/authorised-36/ema_medicine_types/field_ema_med_biosimilar/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar (2019).

  2. US Food & Drug Administration. Biosimilar product information. FDA https://www.fda.gov/drugs/biosimilars/biosimilar-product-information (2019).

  3. Dorner, T. & Kay, J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat. Rev. Rheumatol. 11, 713–724 (2015).

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  4. Goll, G. L. et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J. Intern. Med. 285, 653–669 (2019).

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  5. Glintborg, B. et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann. Rheum. Dis. 78, 192–200 (2019).

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  6. Gasteiger, C. et al. The effects of message framing on patients’ perceptions and willingness to change to a biosimilar in a hypothetical drug switch. Arthritis Care Res. https://doi.org/10.1002/acr.24012 (2019).

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  7. Jørgensen, K. K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 389, 2304–2316 (2017).

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  8. Rådet for Anvendelse af Dyr Sygehusmedicin. RADS anbefaling vedrørende brug af biosimilært infliximab og etanercept [RADS recommendation regarding the use of biosimilar infliximab and etanercept]. regioner.dk https://www.regioner.dk/media/3488/rads-notat-om-anvendelsen-af-biosimilaere-juni-2016.pdf (2016).

  9. Tweehuysen, L. et al. Open-label, non-mandatory transitioning from originator etanercept to biosimilar SB4: six-month results from a controlled cohort study. Arthritis Rheumatol. 70, 1408–1418 (2018).

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Correspondence to Jonathan Kay.

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Competing interests

J.K. has received research support (paid to the University of Massachusetts Medical School) from Gilead Sciences, Pfizer and UCB and has served as a consultant to Alvotech Suisse, Boehringer Ingelheim, Celltrion Healthcare, Horizon Therapeutics, Kolon TissueGene, Merck Sharp & Dohme, Mylan, Novartis, Pfizer, Samsung Bioepis, Sandoz and UCB.

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Kay, J. Overcoming barriers to biosimilars in inflammatory arthritis. Nat Rev Rheumatol 16, 65–66 (2020). https://doi.org/10.1038/s41584-019-0359-7

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