FDA Draft Guidance: Bispecific Antibody Development Programs

Today the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Bispecific Antibody Development Programs. This draft guidance provides recommendations to assist industry and other parties involved in the development of bispecific antibodies.  The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody.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.  

Since the first therapeutic monoclonal antibody was commercialized in 1986, monoclonal antibodies have become a vital component of therapy for various diseases and conditions including cancer, autoimmune and infectious diseases, and inflammatory conditions.  The regulatory pathway for evaluation of monoclonal antibodies is well established, but additional draft guidance is needed about antibody-based products that target more than one antigen (e.g., bispecific antibodies).  

Comments on this draft guidance will be collected for 60 days following publication through the related docket (FDA-2019-D-0621).