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U.S. New Drug Application & FDA Approvals → Biologic License Application (BLA)

BLA is for biologics what an NDA is for small molecule drugs: It is the request for marketing approval for a biologic product.

Regulation: The FDA’s Center for Biologics Evaluation and Research (CBER) regulates BLAs similarly to CDER regulating NDAs.

Components of the BLA: Just like with an NDA, the BLA includes information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and efficacy of the biologic.

What Are Biologics and Why Are They Regulated Differently than Small Molecules?

  • Biologics are made from “living” sources, typically DNA, and involves protein expression in a living cell. Biologics allow much greater specificity and complexity of treatment.
  • They are commonly derived from bacteria/viruses, human or animal cells, tissue, organs, or plants.
  • Due to the structure of these compounds, they have different manufacturing, labelling, and storage requirements than small molecule drugs, hence the designated FDA CBER regulatory body.