The interchangeability of biosimilars can sometimes be an emotive subject. Despite reservations by prescribers, payers and patients, many countries have implemented policies allowing for the substitution of biologicals with biosimilars. However, there is still a lack of harmonization around the world when it comes to how different countries or regions approach the interchangeability of biosimilars [1].
Interchangeability is also defined differently in different countries and regions. In the European Union (EU) interchangeability is defined as ‘the medical practice of changing one medicine for another that is expected to achieve the same clinical effect in a given clinical setting and in any patient on the initiative, or with the agreement of, the prescriber’ [2].
Replacement of one product by another can be achieved by switching, which is a decision made by a physician, or by (automatic) substitution at the pharmacy level. However, in Canada and the US, interchangeability refers to automatic substitution but not switching. In the US, ‘the biological product may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product’ [2]. Whereas in Canada, the authorization of a biosimilar is not a declaration of equivalence to the reference biological. Decisions on interchangeability are made by each province and territory according to its own rules and regulations.
The different policies in use in different countries around the world was investigated in a survey carried out by World Health Organization (WHO) in 2019‒2020, see Table 1 [3]. The survey found that in most of the participating countries, interchangeability refers to switching and automatic substitution is not accepted. In fact, the survey found that automatic substitution of biosimilars was practised only in Iran and Japan.
| Table 1: Approaches to the interchangeability of biosimilars
|
| Country/region
|
Automatic
|
Clinical evidence
|
Prescriber decision
|
| Brazil
|
-
|
Yes
|
Yes
|
| Canada*
|
-
|
-
|
Yes
|
| China
|
-
|
-
|
Yes
|
| Cuba
|
-
|
Yes
|
Yes
|
| Egypt
|
-
|
-
|
Yes
|
| EU
|
-
|
-
|
Yes
|
| Ghana
|
-
|
Yes
|
Yes
|
| India
|
-
|
-
|
Yes
|
| Indonesia
|
-
|
-
|
Yes
|
| Iran
|
Yes
|
-
|
-
|
| Japan
|
Yes
|
-
|
-
|
| Jordan
|
-
|
-
|
Yes
|
| Malaysia
|
-
|
-
|
Yes
|
| Peru
|
-
|
Yes
|
Yes
|
| Russia
|
-
|
Yes
|
Yes
|
| South Korea
|
-
|
-
|
Yes
|
| Singapore
|
-
|
-
|
Yes
|
| Thailand
|
-
|
-
|
Yes
|
| Zambia
|
-
|
Yes
|
Yes
|
*In Canada the decision to introduce automatic substitution of biosimilars is made at the provincial level. Most of the country leaves the decision to the prescriber, however, some provinces have introduced automatic substitution [4].
EU: European Union; WHO: World Health Organization.
Source: WHO
|
The survey revealed that most countries do not have regulatory guidelines for the interchangeability of biosimilars, but many have adopted national approaches for this.
In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the drug regulator, the European Medicines Agency (EMA), but at the national level. This is despite the fact that biosimilars developed in line with EU requirements are considered by EMA to be therapeutic alternatives to their reference biologicals. This means that automatic substitution of biosimilars is generally not routinely practised [5].
Consequently, several EU countries have issued national guidance, for example, Denmark, Finland and the Netherlands. In addition, medical health societies in the EU have provided guidance on switching from an originator product to the corresponding biosimilar. Particularly in Nordic countries, massive non-medical switches with the supervision of prescribing physicians have taken place due mainly to the purchase of biosimilars by bulk tenders [6].
Conflict of interest
The authors of the research paper [3] declared that there was no conflict of interest.
Editor’s comment
Readers interested to learn more about prescribing biologicals and automatic substitution are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution
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| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Interchangeability of biosimilars around the world [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Reports/Interchangeability-of-biosimilars-around-the-world
2. Derbyshire M. USA and Europe differ in interchangeability of biosimilars. GaBI Journal. 2017;6(4):183-4. doi:10.5639/gabij.2017.0604.039
3. Kang HN, Thorpe R, Knezevic I, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2020 Nov 21. doi: 10.1111/nyas.14522. Epub ahead of print.
4. 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 Oct 5]. Available from: www.gabionline.net/biosimilars/general/Ontario-becomes-third-Canadian-province-to-switch-patients-to-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilar substitution in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Reports/Biosimilar-substitution-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Switching approaches to biosimilars in Nordic countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Reports/Switching-approaches-to-biosimilars-in-Nordic-countries
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