The Evolving Biosimilar Approach

Published on: 
BioPharm International, BioPharm International, Regulatory Sourcebook October 2021, Volume 2021 eBook, Issue 4
Pages: 14–17

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

Europe has the most mature biosimilar market in the world, with the European Medicines Agency (EMA) approving the first biosimilar medicine in 2006. Since the first biosimilar approval, and as correct at the time of writing, the region now has 69 biosimilars approved for use, excluding products that have been withdrawn after approval, before approval, or for applications that were refused by EMA.

Market research shows the biosimilar landscape in Europe is set to continue expansion with double digit compound annual growth rate of 22.1% expected between 2021 and 2026. Key driver for this growth includes the loss of patent protection for several blockbuster biologics in Europe, which will lead to increased competition in the market.

Read this article in BioPharm International’s October 2021 Regulatory Sourcebook eBook.


About the Author

Felicity Thomas is European Editor for BioPharm International.

Article Details

BioPharm International
eBook: Regulatory Sourcebook
October 2021
Pages: 14–17


When referring to this article, please cite it as F. Thomas, “The Evolving Biosimilar Approach,” BioPharm International’s Regulatory Sourcebook eBook (October 2021).