Biologics are generally large, complex molecules and are produced from living organisms or contain components of living organisms.
Biologics are a diverse group of products including vaccines, immune modulators, monoclonal antibodies, phages, and microbiome-derived products. A biologic is manufactured in a living system such as in a microorganism, in plant cells or in animal cells. Biologics are regulated, tested and controlled differently than other drugs, as biologics are licensed via a biologics license application (BLA) whereas drugs are approved via an NDA. To secure a license, the BLA must show that the manufacturing process meets the standards set by the Public Health Service Act (PHSA), “ensuring the product is safe, pure, and potent (i.e., effective).”