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The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.
FDA published guidance on April 18, 2019 giving recommendations for the development of bispecific antibody development programs. General regulatory and scientific considerations for bispecific antibodies are discussed. The agency states in the guidance that the development of a specific individual, bispecific antibody development program should be discussed with FDA. The guidance addresses regulatory, quality, nonclinical, and clinical considerations but does not discuss multitarget therapies that are combinations of monoclonal antibodies or are antibody cocktails or polyclonal antibodies.
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.