Biological standardization
WHO Guidelines on evaluation of biosimilars provide regulatory authorities with the scientific principles and approach to be applied during the demonstration of similarity between a biosimilar and its reference product.
WHO provides Biological Reference Materials which serve as reference sources of defined biological activity. These preparations are the basis of a uniform reporting system, helping physicians, scientists, regulatory authorities, and manufacturing settings to communicate in a common language for designating the activity or potency of biological preparations.
This tool includes information on written standards, reference materials, and implementation of biological standardization.