More national guidance needed on biosimilars in Europe Posted 08/01/2021

A poster presented at the Virtual ISPOR (International Society for Pharmacoeconomics and Outcomes Research) 2020 conference outlines the importance of regulatory guidance on biosimilar medicines in Europe.

Lack of knowledge about biosimilars can be a major barrier to their use. For example, a recent report on biosimilar uptake in the US found that a lack of understanding of biosimilars among providers is a significant barrier to their widespread use [1].

Recent research led by KU Leuven University in Belgium has investigated the importance of regulatory guidance on biosimilars, as well as the perspectives of healthcare professionals, in Europe [2].

The researchers performed a literature review, screened the websites of the European Medicines Agency (EMA) and National Competent Authorities (NCAs) in Europe, and performed interviews with healthcare professionals and industry representatives in Europe. All elements of the research focused on biosimilars.

The results of the interviews showed that healthcare professionals and industry representatives consider EMA and the NCAs to play a crucial role in informing them about biosimilars, with EMA considered the primary information source by most respondents. EMA was considered the primary source as it is thought to provide comprehensive and trustworthy information.

The website analysis however found that 42% of NCA websites did not contain any information on biosimilars. Although 48% of websites did contain educational materials on biosimilars, almost half of these relied on material taken directly from EMA.

Overall, the research highlights the need for greater guidance on biosimilars from NCAs. In particular, more guidance is needed on interchangeability, switching and substitution of biosimilars, as the majority of NCA websites did not contain any information on these issues.

Related articles
Pharmacists are key to quality use of medicines for biosimilars

Biosimilar education gaps in oncology

Biosimilar education for Canadian nurses


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.



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 Latin América.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. US policy brief identifies barriers to biosimilars uptake []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from:  
2. ISPOR. The role of regulatory guidance and information dissemination for biosimilar medicines - the perspective of healthcare professionals and industry [homepage on the Internet]. [cited 2021 Jan 8]. 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 © 2021 Pro Pharma Communications International. All Rights Reserved.

Source: ISPOR

Comments (0)