A New Biologic Entity (NBE) is a newly developed biologic medicine that contains an active ingredient never before approved by the FDA. These drugs are made from living cells and are often used to treat complex diseases like cancer or autoimmune disorders. Some examples of new biologic entities include vaccines, monoclonal antibodies, recombinant therapeutic proteins, proteins, sugars, nucleic acids, blood, and blood components.
In medicine, NBEs represent innovation in therapy, offering new treatment options for conditions with limited existing solutions.
Find laboratories or medical organizations performing research or have data on NBEs with Nexus.
Sources
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals. U.S Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals
New FDA drug approvals for 2024: Synthesis and clinical application. European Journal of Medicinal Chemistry. https://www.sciencedirect.com/science/article/abs/pii/S0223523425000066