FDA Announces Proposed Rule to Aid in Products' Transition to Biologics and Biosimilars

The FDA today announced a proposed rule that would amend regulations concerning the use of master files for biologics. According to the FDA, this rule is necessary to avoid any disruption to products that will transition from regulation as drugs to regulation as biologics in 2020.

The rule applies to products that are currently approved under the Federal Food, Drug, and Cosmetics Act but are slated to be transitioned to licensure under the Public Health Service (PHS) Act in March 2020, and it would allow these products to continue to rely, by reference, on information on a drug substance, drug substance intermediate, or drug product (DS/DSI/DP) that is contained in master files after the products make their transition.

Master files are submissions to the FDA that can be used to provide detailed, confidential information about topics including facilities, processes, or articles used in the manufacturing, processing, packaging, or storage of a product. The information contained in such a file can be used to support a submission by a drug sponsor, and the FDA generally allows Biologics License Applications to incorporate, by reference, information contained in these files.

The holder of such a file can authorize applicants or sponsors to refer to information in the file in their submissions to the FDA without having to disclose that information—such as trade secrets or confidential commercial information—to the applicants or sponsors. Incorporation by reference allows the FDA to review this information in the file in the context of a regulatory application.

The rule also codifies the FDA’s current practice, which allows a biologic product in a Biologics License Application to incorporate by reference information (other than DS/DSI/DP information) contained in a master file. This type of information may be related to excipients, stabilizers, penetrants, or other materials. However, as a scientific matter, the FDA requires applicants to submit information on DS/DSI/DP directly, without relying on a file, in part because biologics have features that can be sensitive to changes in manufacturing processes.

However, the FDA allows the use of DS/DSI/DP information in Investigational New Drug Applications, in part to help facilitate development; the new rule would also codify this practice for products subject to the PHS Act.

The FDA says that, to date, it has identified approximately 89 products that will transition, and approximately 17 of them currently incorporate by reference information on DS/DSI/DP.

The FDA will receive comments on the proposed rule for 60 days after the rule is published in the Federal Register.