Biologics are licensed rather than approved, under a different section of law from small molecules. That distinction drives the separate biosimilar pathway and the separate miscellaneous code J3590.
The application for a biological product — a monoclonal antibody, vaccine, cell or gene therapy.
Biologics are licensed rather than approved, under a different section of law from small molecules. That distinction drives the separate biosimilar pathway and the separate miscellaneous code J3590.