The US needs to learn from Europe to increasing access to biosimilars

Biosimilars/Research | Posted 18/02/2022 post-comment0 Post your comment

Europe has been leading the way when it comes to encouraging the use of biosimilars. This is especially true in Scandinavian countries, such as Norway, which are seen as leading the way when it comes to switching and substitution of biosimilars in Europe [1]. In fact, an analysis by Norwegian researchers has found that ‘tremendous savings’ could be realized in the US should the country implement similar strategies [2].


The problem is that biosimilars currently make up only 2.3% of the US biologicals marketplace. Currently, 90% of global biosimilars sales take place in Europe, despite 60% of overall biologicals sales occurring in the US [3].

In order to investigate this, author Kvien and colleagues reviewed the challenges to increased biosimilar use in the US and the successful strategies employed to increase biosimilar uptake in the European Union (EU).

The authors found that obstacles to biosimilar uptake in the US included:
• reimbursement and rebates
• patent litigation
• physician and patient concerns

The authors recommended the following actions to increase biosimilar use in the US:
• US government
- Increase approvals (decrease patent litigation)
- Introduce national tender systems, such as those in Denmark and Norway
- Relaxation of requirements for interchangeability

• Healthcare systems
- Financial incentives to healthcare systems
- Reducing rebates for originator biologicals

• Medical associations
- Promotion of biosimilar use
- Education about the efficacy and safety of biosimilars

The authors found that ‘the EU has demonstrated strategies that work’. They add that the US needs ‘to adapt those strategies’ to fit its own healthcare system ‘to alleviate some of its financial burden and to increase access of patients to medications that might otherwise be unaffordable to them’.

They concluded that ‘greater utilization of biosimilars in the US is an achievable goal but the federal government, pharmaceutical companies, and medical associations/institutions will need to work together to address patient and physician concerns and to remove incentives for using more expensive treatment options’.

Conflict of interest
The authors of the research paper [2] declared that there was no conflict of interest.

Editor’s comment
Readers interested to learn more about biosimilar policies in Norway are invited to visit to view the following manuscript published in GaBI Journal:

Norway, biosimilars in different funding systems. What works?

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.2 – CiteScoreTracker 2021 (Last updated on 7 February 2022)

Submit a manuscript to GaBI Journal

Related articles
How do the biosimilar markets in the US and Europe compare?

European uptake of biosimilars


The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View last week’s headline article: Biosimilares aprobados en Colombia

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de la semana pasada: Biosimilares aprobados en Colombia

iExplore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


1. GaBI Online - Generics and Biosimilars Initiative. Switching approaches to biosimilars in Nordic countries []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from:
2. Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022;52:151939.
3. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010