Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry guidance is to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach.

For this guidance, a therapeutic protein refers to a protein that is being developed for licensure, or is licensed, as a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262). Therapeutic proteins include purified monoclonal antibodies, cytokines, enzymes, and other novel proteins for in vivo use. Therapeutic proteins do not include proteins intended to act as vaccines or allergenic products, cellular and gene therapy products, and/or human cells, tissues, and cellular and tissue-based products.5 Although this guidance applies to therapeutic proteins, many of the general principles may be applicable to other biological products, such as novel products regulated by CBER (e.g., cellular and gene therapies).