The Biologics License Application is the regulatory pathway for approval of biological products, a category that includes vaccines, blood products, gene therapies, cellular therapies, and therapeutic proteins produced through biotechnology. Unlike chemically synthesized drugs covered by NDAs, biological products are derived from living organisms and characterized by their manufacturing process as much as by their molecular structure. The BLA provides evidence that the biological product is safe, pure, and potent for its intended use.

The BLA shares the same Common Technical Document format as the NDA, but with additional emphasis on manufacturing characterization reflecting the complexity of biological products. Because slight variations in manufacturing can alter the biological activity of these products, the process is considered part of the product, requiring detailed description and control of all aspects of production. The BLA must demonstrate that manufacturing processes consistently produce a product meeting established specifications and that appropriate testing ensures each lot meets release criteria before distribution.

FDA review of BLAs involves both the Center for Biologics Evaluation and Research (CBER) and, for certain therapeutic biologics, the Center for Drug Evaluation and Research (CDER). The review evaluates the totality of evidence regarding safety and efficacy from clinical trials, the adequacy of manufacturing processes and controls, and the appropriateness of proposed labeling. Facility inspections verify that actual manufacturing conditions match the described processes and that current Good Manufacturing Practice regulations are followed. Upon approval, the biological product receives a license number, and each manufacturing facility must be separately licensed.