ABSTRACT
When the patent of a brand-name drug expires, other drug products usually seek market authorization. Chemically based drugs having small molecules, the alternatives are generic products; with biologically based drugs having large molecules, the alternative products are biosimilars (or termed subsequent-entry biologics in Canada). Regulatory authorities compare the relevant properties of the generic or biosimilar product with those of the original, brand-name drug. As a result of the comparison, bioequivalence of the generic formulation or biosimilarity of the biosimilar product with the brand-name drug could be declared, and market authorization could be granted (Chow, 2011, 2013).
