Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review
Authors: Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens, Arnold G. Vulto, Martijn R. van der Plas & Helga Gardarsdottir
“Biosimilars are not identical like generics, but highly similar versions where demonstrating biosimilarity of quality attributes (QAs) to a reference product is the basis of development and regulatory approval. Information on QAs assessed to establish biosimilarity may not always be publicly available, although this information is imperative to understand better the science behind biosimilars approval. This study aims to identify QA types reported in publications presenting biosimilarity assessments of (intended) biosimilars over time”….to read the full article click here
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