Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry | FDA

Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry | FDA





FDA Issues Draft Guidance for Industry, “Drug-Drug Interaction Assessment for Therapeutic Proteins”

The Food and Drug Administration has issued a draft guidance for industry entitled, “Drug-Drug Interaction Assessment for Therapeutic Proteins Draft Guidance for Industry.” The draft guidance assists sponsors of investigational new drugs and applicants of biologic license applications determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing a systematic, risk-based approach.

Therapeutic proteins are proteins that are licensed as therapeutic biological products under section 351 of the Public Health Service Act (42 U.S.C 262). This guidance describes considerations for assessing DDIs between a therapeutic protein and small molecules or between therapeutic proteins, the types of DDI assessments and design considerations, and labeling recommendations. The guidance emphasizes consideration of the mechanisms of a potential DDI, taking into account the pharmacology and clearance of the therapeutic protein as well as co-administered medications in the patient population, and includes examples of the types of situations in which an assessment of the DDI potential of a therapeutic protein can be warranted. This guidance supplements the final FDA guidances entitled “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,” published in January 2020. 

The FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the public docket (Docket No. FDA-2020-D-1480) available at https://www.regulations.gov up to 90 days following publication in the Federal Register.