medical Definition of biosimilar
- 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
- biosimilar drugs
biosimilarityplay \-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), 28 June 2007