Biologics license application
Biologics License Application (pronunciation: bio-log-ics li-cense ap-pli-ca-tion) is a submission that is made to the Food and Drug Administration (FDA) to market a biologic product in the United States. The application is intended to provide detailed information about the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product. If the information provided meets FDA standards, the application is approved and a license is issued allowing the firm to market the product.
Etymology
The term "Biologics License Application" is derived from the process of applying for a license to market biologic products. "Biologics" refers to products that are derived from living organisms, which can include humans, animals, and microorganisms such as bacteria or yeast.
Process
The Biologics License Application process begins with preclinical testing, which includes laboratory and animal testing. If the results of the preclinical testing show that the product is safe and effective, the company can submit an Investigational New Drug (IND) application to the FDA. The IND application must include data from the preclinical testing, as well as a plan for testing the product in humans.
If the IND application is approved, the company can begin clinical trials. These trials are typically conducted in three phases and involve testing the product on a small number of healthy volunteers (Phase 1), a larger group of people who have the disease or condition the product is intended to treat (Phase 2), and a large group of patients in a randomized and blinded study (Phase 3).
Once the clinical trials are complete, the company can submit a Biologics License Application. The application must include data from the clinical trials, as well as information about the manufacturing, processing, packaging, and labeling of the product.
Related Terms
See Also
- New Drug Application (NDA)
- Therapeutic Goods Administration (TGA)
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