On the edge of transition: European biosimilar clinical trial requirements

Biosimilars/Research | Posted 31/05/2021 post-comment0 Post your comment

Recent debates have focused on the clinical trial requirements for biosimilar approval [1-4]. Further, the regulatory approval of biosimilars in the European Union (EU) has been changed, where in some instances and under certain conditions clinical trials to establish comparable efficacy have been excluded [4]. Still, the regulatory recommendation for more complex molecules such as monoclonal antibodies is without exception to conduct clinical comparability trials [4].

Clinical Trials 2 V13K29

It is at present unclear to what extent a further reduction of clinical comparability requirements would be acceptable, and therefore, Druedahl et al. [5] investigated the perceptions of industry and medicines agency regulators regarding the value, necessity and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity.

The study used qualitative interviews, in which the participating EU national medicines agency regulators and industry experts predicted that biosimilar clinical trial requirements for comparable efficacy would be further reduced in the near future. These predictions were based on, amongst others, the advancements in analytical testing of recombinant proteins and the knowledge generated from former biosimilar approvals.

Overall, the participants expressed scientific arguments for reducing the European biosimilar clinical trial requirements, which included that analytics and science were sufficiently developed and that clinical trials would be unethical if not scientifically justified. They said that the non-scientific consequences were that it would lower biosimilar development costs, making it attractive to develop biosimilars for more originator biologicals.

In general, the participants stated that scientific argument against reducing the European biosimilar clinical trial requirements was that it was necessary to conduct clinical trials to establish comparable efficacy and immunogenicity. They expressed that non-scientific consequences were that originator companies could become disincentivized if competition was introduced too easily and that physicians could become more reluctant to prescribe biosimilars.

Druedahl et al. concluded that there is a need for clarity on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamics studies and the drugs’ performance in the clinic, as well as how to continue sufficient immunogenicity assessment. It is, however, likely that the European biosimilar clinical trial requirements will change in the near future.

Conflict of interest
The authors of the research paper have declared their funding and conflict of interest in the research paper [5].

Abstracted by Louise C Druedahl, MSc Pharm, PhD, Copenhagen Centre for Regulatory Science (CORS)/Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark.

Editor’s comment
Readers interested to learn more about the data requirements to demonstrate biosimilarity in the EU are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Data requirements to demonstrate biosimilarity in the EU

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.


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 Latinoamérica.

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

Related article
Standardizing clinical trials for biosimilars

1. Allocati E, Bertele V, Gerardi C, Garattini S, Banzi R. Clinical evidence supporting the marketing authorization of biosimilars in Europe. Eur J Clin Pharmacol. 2020;76(4):557-66.
2. Frapaise FX. The end of phase 3 clinical trials in biosimilars development? BioDrugs. 2018;32(4):319-24.
3. Webster CJ, Wong AC, Woollett GR. An efficient development paradigm for biosimilars. BioDrugs. 2019;33(6):603-11.
4. Wolff-Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU Biosimilar Framework: Past and Future. BioDrugs. 2019;33(6):621-34.
5. Druedahl LC, Kälvemark Sporrong S, van de Weert M, De Bruin ML, Hoogland H, Minssen T, et al. Evolving biosimilar clinical requirements: a qualitative interview study with industry experts and European National Medicines Agency regulators. BioDrugs. 2021;35(3):351-61.

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.

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