A Biological Product means a vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug.
Biological products, or biologics, are medical products made from a variety of natural sources (human, animal or microorganism) intended to treat diseases, prevent or diagnose diseases. Examples of biological products include vaccines, blood and blood products, human cells and tissues, gene therapies and cellular therapies.