FDA draft guidance suggests comparing bispecifics to monospecific antibodies

Demonstrated efficacy of a bispecific antibody against monospecific products targeting the different antigens could be a requirement for gaining FDA approval, according to draft guidance released Thursday.

The guidance describes non-clinical and clinical recommendations for the development of bispecific antibodies. Among the clinical recommendations was the suggestion that a comparison study against each of the monospecific components could be warranted if there is concern that only one of a bispecific's targets is driving efficacy...