Expanding the Product Shelf

Abstract

Biologic therapy has been growing for decades thanks to the advancement of biological sciences and research. In the United States, biological products and their highly similarity but with cost-saving, called biosimilar, are regulated by two FDA's centers, the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The CBER is responsible for vaccines, allergenic products, human blood products, etc., while the CDER is responsible for nonhuman animal/solid human tissues, monoclonal antibodies, protein therapeutics, etc. To be permitted to release to the market, a biological product must be reviewed and approved by the FDA from the results of pre-clinical and clinical testing. After clinical testing approval, the biological product will undergo the Biologic License Application (BLA) instead of the New Drug Application (NDA), which is required for other chemical-derived products. The biological product must meet the requirements of purity, potency, and safety. In the case of emergency for public use, such as pandemic, the biological product (e.g., vaccine) can be under the Emergency Use Authorization (EUA) regulation. Under EUA, the biological product still meets the requirements of purity, potency, and safety for use, but the BLA has not been issued. The permit for use is valid only during emergency time. After that, the biological product still needs to be under further review for the FDA's BLA full regulatory approval. A subset of a biological product is biosimilar, which is developed from the pattern of an approved biological products after the latter's patent is expired. Biosimilar is required to meet the requirement of “high similarity”, as compared to its reference approved biological product. Unlike the reference product, biosimilar undergoes more largely analytical testing for purity and potency, then non-clinical, and smaller testing on clinical pharmacology/pharmacokinetics and finally additional clinical studies. There are more approved biological products than biosimilars. The import of biological products is processed by the U.S. Customs and Border Protection (CBP), and the products are regulated by the FDA. With the advancement of biological products and biosimilars, the FDA is facing more challenging in the regulatory and possibly ethnic and legal.