Biosimilars are biological products that are highly similar to their reference biologicals. Biosimilars are designed to have comparability with respect to quality, safety and efficacy compared to an already licensed reference biological. Most regulatory agencies, including the European Medicines Agency (EMA), do not require a full clinical dossier for a biosimilar. It is usually possible to carry out one clinical trial in one indication, with the option to extrapolate to other indications of the reference biological [1].
In Canada, policies to switch patients to biosimilars were introduced in several provinces, including Alberta, British Colombia and Ontario, in 2020 [2]. However, while drug policy experts and some rheumatologists are praising the adoption of these policies that favour biosimilars, others have concerns about non-medical switching of stable patients.
On this subject, authors from Canada discussed whether biosimilars have kept the promises that they appear to make [3]. They start with the statement that biosimilars have promised to reduce treatment costs to ensure that more patients have access to these therapies without impacting the sustainability of the healthcare system. However, they find that there is no public oversight that confirms that these promises have been kept and that the actual price of the biosimilars themselves is reduced, rather than the savings being achieved by curtailing patient support programs (PSPs). Based on this situation, healthcare professionals (HCPs) must ensure well-developed and effective PSPs are set in place by manufacturers to ensure patient care is the priority.
They add that HCPs should call for attention to all involved stakeholders about the need for the off-label use of biosimilars in medical practice to ensure patients have access to them. Finally, they recommend that HCPs request provincial post-implementation surveillance to assess ongoing responses to biosimilar policies.
The authors end by stating that vigilance and action are needed to ensure that promises are met.
Conflict of interest
The authors of the research paper [3] reported conflict of interest, including having received funding from pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [3].
Abstracted by Sylvia A Martinez-Cabriales, Division of Dermatology, Department of Medicine, University of Toronto, and Department of Dermatology, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.
Editor’s comment
Readers interested to learn more about substitution policies for biosimilars in Canada are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
A critical review of substitution policy for biosimilars in Canada
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Law and ethics of switching to biosimilars in Canada
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References
1. GaBI Online - Generics and Biosimilars Initiative. Tailored and reduced clinical programme for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from: www.gabionline.net/reports/Tailored-and-reduced-clinical-programme-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Ontario becomes third Canadian province to switch patients to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from: www.gabionline.net/biosimilars/general/Ontario-becomes-third-Canadian-province-to-switch-patients-to-biosimilars
3. Martinez-Cabriales SA, Manion R, Shear NH. Biosimilars: Promises Made. Promises Kept? J Cutan Med Surg. 2021;25(3):241-42.
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