While biosimilars and generics have some conceptual parallels, the complexity of biologic medicines means that the principles relevant to the evaluation and use of generic medicines cannot be simply extrapolated to biosimilars10.
Biosimilars and generics are both alternative versions of branded, originator medicines for whom marketing exclusivity rights have expired. They are also both approved through abbreviated pathways that do not require duplicating full clinical trials11.
However, as generic medicines are comprised of small, chemical molecules, demonstration of bioequivalence between a generic and reference product is generally sufficient to infer therapeutic equivalence between the two12. Due to the complexity and inherent structural variability of reference biologics and biosimilars, the method established for generic medicines is not suitable for the development and evaluation of biosimilars12.