How biosimilar competition in Europe is changing

Home/Reports | Posted 25/03/2022 post-comment0 Post your comment

A report carried out at the request of the European Commission found that the development of access to biologicals in Europe remains challenging [1].

Biosimilar biological 800x345 V21L05

The report, which was carried out by data analysis firm IQVIA, found that the competitive environment in Europe for biosimilars is changing.

When originator biologicals lose patent protection there are increasingly rapid biosimilar penetration rates. In fact, biosimilars launched in the past year have reached 50% penetration of the originator within less than one year. This compares to previous biosimilars, which took more than two years to reach an equivalent position and older biosimilars, which still have lower penetration.

Biosimilar makers are much more prepared for immediate launch upon loss of exclusivity and there are also more biosimilar manufacturers entering the market.

The European biosimilar market has benefited from research by a broad spectrum of companies from across the globe, willing and able to develop complex biologicals. The history of the market has been European dominated, with leading generics’ makers like Sandoz, Ratiopharm and Hexal leading the first wave of biosimilar development, alongside global players like Teva and Cipla. This trend is changing as other regions enter the biosimilar space, resulting in growth internationally and the emergence of new players that are preparing to launch their first biosimilars.

The problem with non-originator products approved outside of the European Union (EU) is that the regulatory and development processes are not directly interchangeable between regions. European Medicines Agency (EMA) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product. While another problem for potential biosimilars makers from outside the EU are the somewhat opaque rebate and discount procedures.

Finally, the high upfront investment and production costs coupled with pricing pressures and limited access are raising the bar for biosimilar developers and may make Europe more dependent on imported medicines.

Conflict of interest
The authors of the report [1] did not provide any conflict-of-interest statement.

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

Biosimilar competition in Europe

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.

Related articles
Preparing for future biosimilar opportunities

Developing access to biologicals remains challenging

Savings from biosimilars reached an all-time high in 2021

Impact of the COVID-19 pandemic on biologicals

Impact of biosimilar competition in Europe in 2021


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: Nomenclatura de biológicos y biocomparables en México

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: Nomenclatura de biológicos y biocomparables en México

!Explore 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. Troein P, Newton M, Scott K, et al. The impact of biosimilar competition in Europe: December 2021. IQVIA.

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