Biological Drug Terms and Definitions (1921)

BiologicsProducts composed of sugars, proteins, nucleic acids, and/or cells or tissues used to prevent, treat, or cure a disease or condition in humans. Products include vaccines, blood and blood components, allergenic products, and recombinant therapeutic proteins.
Originators (References)First biologics approved against which future related biologics are evaluated.
BiosimilarsBiologic that is highly similar to a reference product (i.e., originator) with no clinically meaningful difference in purity, potency, and safety.
InterchangeablesBiologics that meet the requirements of biosimilars and produce the same clinical result as the originator in any patient. The risk of reduced efficacy or increased adverse events from switching to the interchangeable or alternating between the interchangeable and the originator should be no greater than the risk associated with continuous use of the originator.