Abstract

A‘biosimilar’is a biotherapeutic product that has provensimilarity interms of quality, safety and efficacy to a licensed reference product(RP) (Table 1). The term‘biosimilar’was introduced for biologicsbecause their complexity makes it impossible to make an identicalcopy. In contrast, a‘generic’is an exact copy of a small-molecule drugwith a known chemical structure and a fixed number of atoms. Withpatent expiries of biologics, biosimilars have been proclaimed as ameans to broaden access to treatment and reduce costs.