biosimilar

noun

bio·​sim·​i·​lar -ˈsi-mə-lər, -ˈsim-lər 

: a substance of biological origin (such as a globulin, vaccine, or hormone) that is used in the prevention or treatment of disease and is highly similar to a previously-approved proprietary biologic

Note: Biosimilars must be found to have no clinically significant difference to the previously-approved biologic and only vary in their clinically inactive components.

Under the BPCI Act, biosimilars will also have the opportunity to meet a higher standard of similarity to a reference product—"interchangeability," reflecting an FDA assessment that pharmacists can make substitutions between biologics without the prescriber's intervention.

—Steven Kozlowski et al., The New England Journal of Medicine

biosimilar adjective

biosimilar drugs

biosimilarity

-ˌsi-mə-ˈler-ə-tē 

noun

A demonstration of biosimilarity will have to include analytical data, animal testing and one or more clinical studies, unless such a requirement is determined by the FDA to be unnecessary.

—Robert Cohen, The Star-Ledger (Newark, New Jersey)