Instead of an NDA, what is submitted for a biologic drug?

• A. New Drug Application
• B. Abbreviated New Drug Application
• C. Biologics License Application
• D. Investigational New Drug Application

Answer: (C)

Biologics are licensed through a Biologics License Application rather than a traditional NDA because biologics are more complex and are regulated under a separate pathway within the FDA. The Biologics License Application is the submission used to obtain approval to market a biologic after completing clinical trials. In contrast, a New Drug Application is for conventional small-molecule drugs, an Investigational New Drug Application starts the clinical testing process, and an Abbreviated New Drug Application is for generic versions of small-molecule drugs. By design, the licensing process for biologics (which include vaccines, proteins, monoclonal antibodies, and similar products) falls under the Biologics License Application to reflect their unique manufacturing and regulatory considerations.