
FDA Issues Bispecific Antibody Development Guidance
The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.
FDA published
According to FDA, “bispecific antibodies can target multiple disease-modifying molecules with one drug, with possible advantages over combination therapy or the use of antibody mixtures.” Developing bispecific antibodies can be a challenge, however. The guidance clarifies which type of data are necessary to support the approval of bispecific antibodies.
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