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Chromatographic and electrophoretic assessment of Filgrastim biosimilars in pharmaceutical formulations

Journal of Pharmaceutical and Biomedical Analysis, 2014
An orthogonal testing protocol was developed and validated to assess the quality of Filgrastim biosimilars. Results were compared to those obtained from the innovator product. Initial screening was carried out using reducing and non-reducing gel electrophoresis.
Eman L, Shaltout   +3 more
openaire   +2 more sources

Gel Electrophoretic Methods for The Analysis of Biosimilar Pharmaceuticals Using The Example of Recombinant Erythropoietin

Bioanalysis, 2013
Due to their versatility and cost-effectiveness, gel electrophoretic methods provide an important set of tools for the analysis of therapeutic proteins. As an increasing number of biosimilar pharmaceuticals are entering the market, techniques are required that allow reliable demonstration of comparability of these products with the reference products ...
Christian, Reichel, Mario, Thevis
openaire   +2 more sources

Biosimilars and Information Exchange in Australian Pharmaceutical Patent, Trade Secret and Data Exclusivity Arrangements

2022
More specifically, this thesis examines the information exchange between originator manufacturers and biosimilar manufacturers related to patents and data exclusivity, and how the information exchange affects biosimilars and biosimilar development.
openaire   +1 more source

Outlook For Biosimilar Molecules Entering Croatian Pharmaceutical Market In The Period From 2016 To 2020

Clinical Therapeutics, 2016
R, Likic   +7 more
openaire   +2 more sources

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