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
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, 4 Aug. 2011
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