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The Evolving Biosimilar Approach
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The Evolving Biosimilar Approach
Publication
Article
BioPharm InternationalBioPharm 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.
Christoph Burgstedt - Stock.adobe.com
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correct at the time of writing, the region now has 69 biosimilars approved for use, excluding products that have been withdrawn after approval, before approval, or for applications that were refused by EMA.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
Citation
When referring to this article, please cite it as F. Thomas, “The Evolving Biosimilar Approach,” BioPharm International’s Regulatory Sourcebook eBook (October 2021).
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Industry Organizations Assist Pharma During the Pandemic and Beyond
NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations
How Artificial Intelligence Impacts the Global Regulatory Environment
Selecting the Right CMC Strategy for Biologics
The Evolving Biosimilar Approach
Serialization and Aggregation from a Manufacturing Perspective
The Real Danger of Substandard and Counterfeit COVID-19 Vaccines
Collecting Industry’s Thoughts on FDA FARS Report
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