Medical Definition of biosimilar
: 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 ◆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, 4 Aug. 2011
biosimilaradjective biosimilar drugs
biosimilarity\-ˌsi-mə-ˈler-ə-tē\ play 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), 28 June 2007
Seen and Heard
What made you want to look up biosimilar? Please tell us where you read or heard it (including the quote, if possible).