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How are biologic products approved?


A biological product is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. For example, biologics include vaccines, various toxoids, skin test antigens, allergenic extracts, blood and blood products, and certain in vitro test kits intended for testing of biological products. The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are issued by the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER). Biological products intended for veterinary use are regulated under a separate law, the Virus, Serum, and Toxin Act, which is administered by the U.S. Department of Agriculture.

CBER has also been delegated authority to regulate certain drugs closely related to biologics, such as anticoagulants packaged in plastic blood collection containers. CBER under the Federal Food, Drug and Cosmetic Act regulates these as drugs. Similarly, some medical devices used in blood banks to produce biologics are regulated by CBER, under the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act. Examples of such devices are automated cell separators, empty plastic containers and transfer sets, and blood storage refrigerators and freezers.

Licensing of biologic products under the PHS Act is very similar to the new drug approval process for human drugs. Following initial laboratory and animal testing, a biological product is studied in clinical trials in humans under an investigational new drug application (IND). If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted to CBER as part of a biologics license application for review and approval for marketing.

After a license application is approved for a biological product, the product may also be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by CBER, the manufacturer submits samples of each lot of product to CBER together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer's tests performed on the lot. CBER may also perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In addition, CBER conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.


Last Reviewed: 04/23/2008