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The Evolving Biosimilar Approach: The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.
- Source :
- BioPharm International; 2021 Special Issue, p14-17, 4p
- Publication Year :
- 2021
-
Abstract
- The article discusses that the biosimilar landscape in Europe is set to continue expansion between 2021 and 2026, with key drivers for the growth including the loss of patent protection for several biologics in Europe. It mentions that the European Medicines Agency and the Heads of Medicines Agencies have provided comprehensive guidance for manufacturers, sponsors, and marketing authorization holders to clarify the requirements and guide product development.
- Subjects :
- BIOSIMILARS
GUIDELINES
DRUG patents
NEW product development
Subjects
Details
- Language :
- English
- ISSN :
- 1542166X
- Database :
- Complementary Index
- Journal :
- BioPharm International
- Publication Type :
- Periodical
- Accession number :
- 159278322