Table 1.

The difference between biosimilars and generics

A generic is a copy of a an existing small-molecule-based therapeutic and its approval is based on the demonstration of bioequivalence with its reference product by appropriate pharmacokinetic studies.2,27

A biosimilar is a biological medicinal product that is highly similar to an already licensed biological medicine, the reference product.2 Owing to the intrinsic variability that is inherent to all biological medicines and the complex manufacturing of these medicines, it is impossible to produce identical products. Minor differences can thus exist between the biosimilar and the reference product, however it needs to be demonstrated that these differences are not clinically meaningful.3

The development of a biosimilar is based on the demonstration of biosimilarity via extensive head-to-head comparability studies to the reference product.2

Generics and biosimilars both follow an abbreviated development pathway for regulatory approval compared with that of an original medicine, however, the requirements are different. As a biosimilar cannot be an exact copy of the reference product, owing to the natural variability and complex manufacturing process of biological medicines in general, the ‘generic’ development and approval approach is not appropriate for a biosimilar.2,27