Bispecific Antibody Development Guidance

FDA has issued a draft guidance, Bispecific Antibody Development Program, to assist industry and other parties involved in the development of bispecific antibodies. The document covers general considerations and recommendations for bispecific antibody development programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. It does not discuss development considerations for other multitarget therapies that are combinations of monoclonal antibodies or are antibody cocktails or polyclonal antibodies.

The guidance focuses on general regulatory and scientific considerations for bispecific antibodies, not on development of a particular bispecific antibody. “Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody development program,” it says.