The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bispecific Antibody Development Programs.” This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.
This draft guidance discusses general considerations and recommendations, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. This draft guidance does not discuss development considerations for other multitarget therapies that are combinations of monoclonal antibodies, antibody cocktails, or polyclonal antibodies.