The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, nonclinical, and clinical considerations.
“This guidance focuses on a range of regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Of note, many aspects of a bispecific antibody development program will be similar to monoclonal antibody development programs. This guidance discusses unique aspects for chemistry, manufacturing, and controls (CMC), as well as nonclinical and clinical development programs for bispecific antibodies. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody development program,” the guidance document states.
The guidance may also apply to the development of other bispecific protein products and multispecific products but does not discuss antibody cocktails, polyclonal antibody products, or combinations of monoclonal antibodies.