Biosimilar
Categories:
Biosimilars
Definition
A biosimilar is a biological medicine that is developed to be highly similar and clinically equivalent to an existing reference medicinal product (RMP). Similarity to the reference medicine must be established based on comprehensive biosimilar testing within comparability studies, demonstrating that there are no clinically meaningful differences in terms of quality, biological activity, safety, efficacy and immunogenicity.
Related Content & Resources
Case Study
European Biosimilar Company – Structural And Physicochemical Characterization And Comparability
Our client is developing a biosimilar to Simponi and required studies including determination of the primary sequence of an EU RMP Golimumab sample and a structural and physicochemical comparability assessment of three EU RMP Golimumab samples.
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