Biologic medicines have led to significant advances in the treatment of patients suffering from serious illnesses. Biologic medicines are large, complex molecules that are made in living cells grown in a laboratory. They are often 200 to 1,000 times the size of a small molecule drug such as aspirin and are much more difficult to manufacture because of their complex structure. It is impossible for a different manufacturer to make an exact replica of a biologic medicine due to several factors, including the inherent complexity of biologics and the proprietary manufacturing process of the original biologic medicine, often referred to as the reference product. It is because of this that copies of biological products are referred to as “biosimilars”; they are highly SIMILAR but not identical to the biologic upon which they are based. Biosimilars have the potential to offer patients and physicians additional options for the treatment of serious illnesses.1 Large-scale production of highquality, reliably supplied biosimilars requires commitment, highly specialized biologics knowledge and experience, infrastructure and capital investment.