Comparability
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Definition
Biosimilar development and approval relies heavily on data obtained from comparability studies that have been performed on the biosimilar and the originator. These studies assess and compare all structural, physicochemical, biophysical and functional attributes of both the originator and the biosimilar and allow a statement to be made about how comparable the two molecules are.
Related Content & Resources
Case Study
Indian Biosimilar Company- Clone Selection for a Biosimilar Monoclonal Antibody
BioPharmaSpec performed a select number of analyses to determine key quality attributes for a number of biosimilar cell clones. The data from this study was used to select promising biosimilar molecules for further development.
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