Clinical comparability and European biosimilar regulations
Publication date
2010
Authors
Schellekens, H.
Moors, Ellen
Editors
Advisors
Supervisors
Document Type
Article
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Abstract
Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are
surplus to requirements and may even be a barrier for the development of biosimilars of more complicated biologics.
Keywords
Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen, Pharmacology