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Maximizing the success of biosimilar implementation

Nature Reviews Rheumatology volume 19, pages 757–758 (2023)Cite this article

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Biosimilars have an important place in the treatment of rheumatic conditions. The non-inferiority of biosimilars to bio-originators is ensured, but full and effective clinical adoption of these agents nonetheless requires consideration of several important issues, including the need for shared decision-making and a potential nocebo effect.

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References

  1. AG Pro Biosimilars. [Biosimilars unter der Lupe]. https://probiosimilars.de/publikationen/marktdaten/ (2023).

  2. Kay, J. et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann. Rheum. Dis. 77, 165–174 (2018).

    Article  CAS  PubMed  Google Scholar 

  3. European Medicines Agency. Biosimilars in the EU. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf (2019).

  4. Cohen, H. P. & McCabe, D. The importance of countering biosimilar disparagement and misinformation. BioDrugs 34, 407–414 (2020).

    Article  PubMed  PubMed Central  Google Scholar 

  5. Alten, R. et al. Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis. Int. J. Rheum. Dis. 23, 1514–1525 (2020).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Cohen, S. B. et al. Long-term efficacy, safety, and immunogenicity of the infliximab (IFX) biosimilar, PF-06438179/GP1111, in patients with rheumatoid arthritis after switching from reference IFX or continuing biosimilar therapy: week 54-78 data from a randomized, double-blind, phase III trial. BioDrugs 34, 197–207 (2020).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Toupin-April, K. et al. Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach. Semin. Arthritis Rheum. 51, 593–600 (2021).

    Article  PubMed  Google Scholar 

  8. Kravvariti, E., Kitas, G. D., Mitsikostas, D. D. & Sfikakis, P. P. Nocebos in rheumatology: emerging concepts and their implications for clinical practice. Nat. Rev. Rheumatol. 14, 727–740 (2018).

    Article  PubMed  Google Scholar 

  9. Dutt, K., Srinivasan, A. & Van Langenberg, D. The nocebo effect in a non-medical switching program from originator to biosimilar infliximab in inflammatory bowel disease. BioDrugs 36, 639–644 (2022).

    Article  CAS  PubMed  Google Scholar 

  10. Glintborg, B. et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann. Rheum. Dis. 76, 1426–1431 (2017).

    Article  CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik, University Medicine, Berlin, Germany

    Rieke Alten & Max Weinbrecht-Mischkewitz

  2. Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

    Max Weinbrecht-Mischkewitz

Authors
  1. Rieke Alten
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  2. Max Weinbrecht-Mischkewitz
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Correspondence to Rieke Alten.

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Competing interests

R.A. declares that she has received honoraria and research grants from Abbvie, BMS, Celltrion, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer and Viatris. M.W.-M. declares no competing interests.

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Alten, R., Weinbrecht-Mischkewitz, M. Maximizing the success of biosimilar implementation. Nat Rev Rheumatol 19, 757–758 (2023). https://doi.org/10.1038/s41584-023-01048-7

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