Monoclonal antibodies are the most successful class of biological products, with an increasing number of approvals in recent years, including the first bispecific antibody (BsAb), blinatumomab in 2014.  Currently there are over 100 BsAb formats including full length IgG structures and modified full length structures, antibody fragment-based structures including Fab, sFv and single V domain structures, fusion proteins and conjugates.  The number of IND submissions representing a few of these formats has increased in the last 3 years, while the majority of the formats are still in pre-clinical development. The complexity of these constructs adds additional development, manufacturing, analytical and regulatory challenges for sponsors and regulators.  This presentation will describe FDA’s experience with BsAbs.<br/>

Regulator’s perspective on challenges in the development of bispecific antibodies

254th National Meeting (2017)

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