BWG Training Manual

Submitted by n.leuba on Thu, 01/21/2021 - 13:59

The Working Group on Biosimilars (BWG) has published a Training Manual for Regulatory Reviewers on The Basics of the Clinical Comparability Exercise for Biosimilar Monoclonal Antibodies.


The manual provides a compilation of publicly available information on the current approach for the clinical comparability exercise for biosimilars, particularly monoclonal antibodies.


The manual is intended to help regulatory reviewers who already have review experience and a certain level of understanding of biotherapeutics, before they begin to review clinical aspects of biosimilars. It could be used as an initiation step in the training of biosimilarity assessments and as a complementary tool and interactive course, such as hands-on training.


More information can be found on the BWG page.