Issue Date: May 24, 2021
Issued by: Center for Biologics Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Bispecific Antibody Development Programs Guidance for Industry
This guidance provides recommendations to assist industry and other stakeholders involved in the development of bispecific antibodies. In addition to general considerations, the guidance provides recommendations for specific regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs. Although this guidance is intended for bispecific antibodies, the principles discussed in this guidance may also inform the development of other types of bispecific protein products and multispecific products. This guidance does not discuss development considerations for other multitarget therapies that are antibody cocktails, polyclonal antibody products, or combinations of monoclonal antibodies.
Download the Guidance Document
