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The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.
FDA published guidance in August 2020 to assist sponsors of investigational new drug (IND) applications and biologic license applications for therapeutic proteins (TPs) in determining the need for drug-drug interaction (DDI) studies. The guidance focuses on therapeutic biological products as defined under section 351 of the Public Health Service Act but may also apply to other biologic products regulated by the Center for Biologics Evaluation and Research.
FDA states in the guidance that “when evaluating the potential for a DDI between a TP and small molecules or between TPs, sponsors should consider the mechanisms of a potential DDI, taking into account the pharmacology and clearance of the TP as well as any co-administered medications in the patient population.” The document gives examples of situations where a DDI of a TP may be needed and recommends “a systematic, science-driven approach to evaluate the DDI potential of TPs.”
The guidance is a supplement to In Vitro Drug Interaction Studies—Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug Interaction Studies—Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.