New Biologic Entity (NBE)

What is a New Biologic Entity (NBE)?

A new biologic entity (NBE) is a biologic compound or vaccine not previously approved for human use by the Center for Biologics Evaluation and Research (CBER).

An NBE can include a vaccine, allergenics, blood and blood components, tissues, somatic cells, gene therapy, and recombinant therapeutic proteins. It can comprise proteins, sugars, nucleic acids, or a combination of these substances. They can also be living entities such as cells and tissues.

An NBE differs from a New Molecular Entity (NME) or a New Chemical Entity (NCE), which are new drugs with active ingredients that have not been marketed before or a novel, small, chemical molecule drug, respectively.

How do NBEs improve healthcare?

An NBE is a new vaccine or other biological compound that has not been previously marketed and sold for individual use. As such, an NBE offers a new method of treating or preventing various diseases and health conditions, which can then provide better health outcomes for the patients to whom it is marketed.