In an effort designed to ensure adequate supplies and to stimulate biosimilars competition, FDA has proposed a new rule that would clarify the use of information contained in drug master files (DMFs) for certain biologics (i.e., hormones and enzymes previously licensed under the Food, Drug and Cosmetics Act [FD&C Act] that will transition to licensing under the Public Health Service [PHS Act] on March 23, 2020).
Currently, FDA does not allow licensed biologics applications to reference DMFs for information on drug substances or intermediates.