FDA Issues Final Guidance on Bispecific Antibody Development Programs

The U.S. FDA issued a final guidance on Bispecific Antibody Development Programs. This final guidance provides recommendations for industry and other parties involved in developing bispecific antibodies, which are antibody-based products that target more than one antigen. These recommendations include general regulatory and scientific considerations for bispecific antibodies. Industry and other stakeholders can engage FDA to discuss their individual bispecific antibody under development. 

With regard to changes from the draft version of this guidance, this final guidance clarifies quality, nonclinical, and clinical considerations when developing bispecific antibodies.

Bispecific antibodies have potential advantages over other therapies, as they can target multiple disease-modifying molecules with one drug. Additional guidance is warranted regarding the regulatory pathway to evaluate bispecific antibodies.