On April 18, 2019, the United States Food and Drug Administration (FDA) issued a draft guidance for industry on the development of bispecific antibodies. This guidance outlines general considerations and recommendations for any new bispecific antibody development program, and also provides specific information regarding quality testing, nonclinical pharmacology and toxicology studies, clinical pharmacokinetic and pharmacodynamic studies, and clinical trial design. The overarching message of the guidance is that any new bispecific antibody development program should be undertaken in consultation with the FDA, and specific development plans should be discussed with the FDA prior to initiation.
This guidance does not address multitargeted compound therapies, such as combinations of monoclonal antibodies, antibody cocktails, and polyclonal antibodies. Moreover, this guidance is currently in a draft state, and the FDA is accepting public comments prior to review, which is scheduled to begin on June 18, 2019.
High Altitude: This guidance is a major step toward standardizing the process for developing these novel biologics. Once finalized, this may help speed regulatory processes by ensuring bispecific antibodies are developed according to FDA recommendations. Similar guidelines exist for other biologic products, including monoclonal antibodies, biosimilars, and antibody-drug conjugates.
Ground Level: As this is a draft guidance and is meant to aid industry in the development of bispecific antibodies, it will not directly impact clinical practice in the short term. If this guidance is adopted, it may ultimately help to maximize quality and accelerate access to bispecific antibody-based therapies for the community physician.