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# Bispecific Antibody Development Guidance
- URL: https://www.fdaweb.com/bispecific-antibody-development-guidance/
- Published: 2021-05-24T12:00:00.000Z
- Updated: 2026-09-14T17:00:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149387

FDA has issued a final guidance entitled [*Bispecific Antibody Development Programs*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTA1MjQuNDA5ODkyNzEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvYmlzcGVjaWZpYy1hbnRpYm9keS1kZXZlbG9wbWVudC1wcm9ncmFtcy1ndWlkYW5jZS1pbmR1c3RyeT91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.ZLi5bzWH06Qz4m2SGqR6CIaX-XHA83fhqZinUP-FOnY/s/1255931999/br/106858116248-l?ref=fdaweb.com) that provides recommendations for specific regulatory, quality, nonclinical, and clinical considerations for such development programs. The document also clarifies quality, nonclinical, and clinical considerations when developing bispecific antibodies. The agency says that many aspects of a bispecific antibody development program will be similar to monoclonal antibody development programs. Additionally,the guidance discusses unique aspects for chemistry, manufacturing, and controls.

FDA says the antibody-based products that target more than one antigen offer potential advantages over other therapies because they can target multiple disease-modifying molecules with one drug. The guidance does not focus on development of a particular bispecific antibody, noting that industry and other stakeholders are encouraged to engage FDA to discuss their individual development programs.