A review by Teixeira FV et al. discusses whether scientific evidence is sufficient to support multiple switches between biologicals and biosimilars in patients with inflammatory bowel diseases (IBD) [1].
IBD currently imposes an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in unavoidable lifetime expenses. The introduction of infliximab more than two decades ago revolutionized IBD treatment. Nowadays, while biological drugs provide various vital therapeutic options for patients, they can be associated with significant costs to healthcare systems.
According to Teixeira et al., the most crucial benefit of biosimilars is that they provide significant cost reductions and increase access to advanced therapies. They also enable the treatment of newly diagnosed patients and allow for dose optimization in those who need it. There is an inverse relationship between the price of biologicals and the demand for treatment. To achieve a more substantial reduction in cost, greater use of biosimilars is necessary. For this to happen, it is essential not only to use biosimilars in naïve patients but also to switch to biosimilars for patients who have already started therapy with reference biologicals.
At present, randomized and observational studies have demonstrated effectiveness and safety in recommending a single switch between a reference product and a biosimilar, and vice versa.
To address the question of whether we are prepared for multiple switches, the authors’ answer is YES. This response is based on robust scientific and clinical evidence accumulated over the past decade since the approval of the first biosimilar monoclonal antibody.
A recent systematic review and meta-analysis by the US Food and Drug Administration (FDA) [2] found no differences in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and those who did not switch.
The authors acknowledged that, although scepticism is warranted due to the relatively recent clinical experience with multiple switches, prospective observational studies have demonstrated efficacy and safety data comparable to that observed with a single switch.
This is evident from the document published by the European Medicines Agency in late 2022, declaring that all monoclonal biosimilars are interchangeable [3]. The authors believe that multiple switches can be carried out effectively and safely; however, this does not negate the need for appropriate counselling, objective assessment of disease activity, and potential side effects before switching, as well as careful follow-up post-switch. This approach will help to ensure optimal patient care while also achieving the financial benefits of a switch policy.
In June 2024, the FDA released updated draft guidance titled ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update’, proposing a revised approach to switching studies. This could potentially lead to all FDA-approved biosimilars being considered interchangeable without the need for additional switching studies [4].
However, some are concerned that removing the interchangeable designation could jeopardize physician confidence and patient health regarding biosimilars [5]. They argued that the US interchangeable standard has helped drive physician and patient confidence and uptake in biosimilars, and advocate for preserving this standard [6].
Conflict of interest
The authors of the research paper [1] declared that there was various conflict of interest.
Abstracted by Fabio Vieira Teixeira, member of the IBD Brazilian Study Group GEDIIB and the European Crohn’s and Colitis Organization, IBD Center, GastroSaude Clinic, Marilia, State of Sao Paulo, Brazil.
Editor’s comment
Readers interested to learn more about switching between biosimilars and reference products are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Non-medical switching of biologicals/biosimilars: Canada, Europe and the US – a webinar report
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References
1. Teixeira FV, Peyrin-Biroulet L, Danese S. Are we ready for multiple switches between reference products and biosimilars?
2. Schrieber S. Switches between biosimilars and their reference products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(3):106. doi:10.5639/gabij.2023.1203.016
3. GaBI Online - Generics and Biosimilars Initiative. EMA calls for biosimilar interchangeability across the EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 13]. Available from: www.gabionline.net/biosimilars/general/ema-calls-for-biosimilar-interchangeability-across-the-eu
4. GaBI Online - Generics and Biosimilars Initiative. FDA interchangeable biosimilars guidance update on revised approach to switching studies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 13]. Available from: www.gabionline.net/guidelines/fda-interchangeable-biosimilars-guidance-update-on-revised-approach-to-switching-studies
5. Reilly MS, McKibbin RD. Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(2): Epub ahead of print.
6. Reilly MS. Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(1):34-6. doi:10.5639/gabij.2023.1301.006
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