Using The 505(b)(2) Pathway To Streamline Regulatory Approval For Combination Products

By Ann Leonard

In recent years, the number of approvals for combination products and 505(b)(2) applications has been rising. Combination products consist of at least two constituent parts, each subject to its own statutory and regulatory requirements. Unlike fixed-dose combination therapies, which consist of drug-drug combinations, combination products can include any of the following:

• A drug and a biologic; for example, a therapeutic drug combined with a monoclonal antibody
• A drug and a device, such as an insulin injector pen
• Two drugs and a device; for instance, a metered-dose inhaler

The U.S. Food and Drug Administration (FDA) has indicated that a single application is appropriate for marketing approval of combination products as determined by the product’s primary mode of action (PMOA), which is the primary mechanism through which a combination product exerts its clinical effect (e.g., chemical versus mechanical).[1]