Docket Number:
FDA-2019-D-0621
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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.

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All written comments should be identified with this document's docket number: FDA-2019-D-0621.